Randomized controlled trials (RCTs) are considered to be the best method for evaluating the effectiveness of medical interventions.1 Despite their strengths, RCTs have substantial limitations.1 Although RCTs have strong internal validity, they occasionally lack external validity and generalizations of findings outside the study population may be invalid. More specifically in retinal surgery, there are many obstacles to conducting RCTs to address the specific questions asked, so the analysis using real-world data is useful.2 Drs Anguita and Charteris wrote an editorial in the British Journal of Ophthalmology (BJO) on the merits and limitations of studies using real-world data.3 They cited our papers that were recently published in BJO which used the data collected in the Japan Retinal Detachment Registry (J-RD registry), and I would like to comment on with a focus on the retinal surgery.4,5
As correctly stated by Drs Anguita and Charteris, studies using the propensity score matching method cannot be performed well if one is not familiar with the limitations of this technique. 3 However, this is also true for those who do not have a deep understanding of the disease and may make incorrect interpretations. This would be the case for our paper4 cited in the editorial. This study compared pars plana vitrectomy (PPV) and scleral buckling for superior RD without macula detachment using the data from the J-RD registry. The results which were analyzed using propensity score...
Randomized controlled trials (RCTs) are considered to be the best method for evaluating the effectiveness of medical interventions.1 Despite their strengths, RCTs have substantial limitations.1 Although RCTs have strong internal validity, they occasionally lack external validity and generalizations of findings outside the study population may be invalid. More specifically in retinal surgery, there are many obstacles to conducting RCTs to address the specific questions asked, so the analysis using real-world data is useful.2 Drs Anguita and Charteris wrote an editorial in the British Journal of Ophthalmology (BJO) on the merits and limitations of studies using real-world data.3 They cited our papers that were recently published in BJO which used the data collected in the Japan Retinal Detachment Registry (J-RD registry), and I would like to comment on with a focus on the retinal surgery.4,5
As correctly stated by Drs Anguita and Charteris, studies using the propensity score matching method cannot be performed well if one is not familiar with the limitations of this technique. 3 However, this is also true for those who do not have a deep understanding of the disease and may make incorrect interpretations. This would be the case for our paper4 cited in the editorial. This study compared pars plana vitrectomy (PPV) and scleral buckling for superior RD without macula detachment using the data from the J-RD registry. The results which were analyzed using propensity score matching showed that there was no significant difference in the best-corrected visual acuity at 6 months after surgery, but there were significantly fewer surgical failures with scleral buckling than with PPV. Thus, we concluded that, “Although the indications for PPV are becoming broader, PPV may not be the optimal approach for repairing all types of RDs. Therefore, careful considerations are needed when selecting the appropriate surgical technique in treating uncomplicated phakic macula-on RD case”, knowing the limitation of evidence level obtained from real-world data study.4 The editorial by Drs Anguita and Charteris indicated that a major problem with this study was the lack of adjustments for the presence or absence of a posterior vitreous detachment (PVD) which is the most important factor in selecting the surgical method.3 Traditionally, the presence of a PVD has been determined by echography, but its accuracy is inferior to that of optical coherence tomography, and above all, it was found to vary from operator to operator.6 On the other hand, it is widely accepted that almost all cases of retinal tears are caused by a PVD,7 so we decided it would be more objective to adjust the evaluations of PVD by using retinal tear or hole instead. We believed that this analysis, in which preoperative factors were adjusted for retinal tear and/or hole, adjusted for PVD to an acceptable level. Without understanding this background, the findings of this paper might be misinterpreted. On the other hand, we mention in the paper by Funatsu et al, which was also cited in the editorial, on the potential toxic effects of silicone.5 There was a misunderstanding of the intent of our study, however because of space limitation, we will not discuss it here.
We agree that the analysis of real-world data using propensity score matching has its limitations.3 However, there are major problems in implementing RCTs in retinal surgery. First, RCTs are very costly, and the overall cost of an RCT study has skyrocketed to a level that cannot be borne by the surgeons or researchers. In recent years, RCTs are no longer conducted unless they are sponsored by large pharmaceutical companies that can profit from the results of RCTs.8 Additionally, if the drug is not effective, it will not necessarily be published.8 Studies in which the company's profit is not clear, such as retinal surgical treatments, are less likely to be adopted as a topic of study. Second, RCT is time-consuming. It usually takes only a few weeks to complete a study using registry data, but it generally takes years to complete RCT studies from planning, implementation, and analyzation. If prospective RCTs were performed for comparing PPV and scleral buckling for superior RD as in our study, it would have taken several years to accomplish the project. Furthermore, it has been noted that RCTs are virtually impossible to perform to compare existing and new surgical methods because surgeons’ preferences already exist and enrollment does not work.9 In general, surgeons want to know how to save the patient in front of them, often an individual problem, as soon as possible. Not only is it extremely difficult to recruit patients for an RCT who meet the inclusion criteria of individual problem of retinal surgery, and it can take several years to obtain the results.9 Thus, it is not practical to use an RCT for this purpose.
The editorial by Drs Anguita and Charteris is very important and I congratulate that. As they stated, we do not believe that the results obtained from real-world data analysis can replace the evidence of RCTs, either. On the other hand, it is true that RCTs cannot answer all of the surgical questions. Most importantly, RCTs are essentially experimental trials of humans. It is unclear whether it will continue to be ethically acceptable to put a large number of subjects at risk even for medical purposes. In contrast, real-world data analyses are basically retrospective studies so it does not expose patients to any new risks. Until better analysis methods are developed, real-world data analysis will provide certain answers to many problems which surgeons have. Nevertheless, I fully agree with them that the researchers and the readers need to recognize the validity and limitations of propensity score matching studies as well as to know the background of the treatment.
REFERENCES
1. Frieden TR. Evidence for Health Decision Making - Beyond Randomized, Controlled Trials. N Engl J Med 2017;377:465-75.
2. Ryan EH, Ryan CM, Forbes NJ, et al. Primary Retinal Detachment Outcomes Study Report Number 2: Phakic Retinal Detachment Outcomes. Ophthalmology 2020;127:1077-85.
3. Anguita R, Charteris D. Could real-world data replace evidence from clinical trials in surgical retinal conditions? Br J Ophthalmol 2022:bjophthalmol-2022-321759. doi: 10.1136/bjophthalmol-2022-321759. Epub ahead of print. PMID: 35580995.
4. Kawano S, Imai T, Sakamoto T; Japan-Retinal Detachment Registry Group. Scleral buckling versus pars plana vitrectomy in simple phakic macula-on retinal detachment: a propensity score-matched, registry-based study. Br J Ophthalmol 2022:857-62.
5. Funatsu R, Terasaki H, Koriyama C, et al. Silicone oil versus gas tamponade for primary rhegmatogenous retinal detachment treated successfully with a propensity score analysis: Japan Retinal Detachment Registry. Br J Ophthalmol 2021:bjophthalmol-2021-319876. doi: 10.1136/bjophthalmol-2021-319876. Epub ahead of print. PMID: 34373251.
6. Moon SY, Park SP, Kim YK. Evaluation of posterior vitreous detachment using ultrasonography and optical coherence tomography. Acta Ophthalmol 2020;98:e29-e35.
7. Michaels RG, Wilkinson CP, Rice TA. Vitreoretinal precursors of retinal detachment. In Retinal detachment, eds Michaels RG, Wilkinson CP, Rice TA, The CV Mosby Company, St Louis, 1990, pp 29-100.
8. Flacco ME, Manzoli L, Boccia S, et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol 2015;68:811-20.
9. Lonjon G, Boutron I, Trinquart L, et al. Comparison of treatment effect estimates from prospective nonrandomized studies with propensity score analysis and randomized controlled trials of surgical procedures. Ann Surg 2014;259:18–25.
We read with interest the manuscript published by Sakamoto et al, on behalf of the Japanese Retina and Vitreous Society, titled: Increased incidence of endophthalmitis after vitrectomy relative to face mask-wearing during COVID-19 pandemic”.[1] In this manuscript, the authors discuss their results after comparing the total prevalence of infectious endophthalmitis among patients that underwent ocular surgery, before and after the peak of the SARS-CoV-2 pandemic in Japan.[1] The authors should be commended due to the level of complexity and significant effort needed to coordinate several centers simultaneously, as well as the detailed description provided in the manuscript regarding the clinical presentation, microbiological results, and outcomes of all cases. Interestingly and despite the low rate of positive vitreous cultures, the authors were able to isolate oral bacteria among several of the cases that developed endophthalmitis during the pandemic, including one caused by Staphylococcus lugdunensis; a pathogen typically hard to eliminate with mechanical washing bacteria, because it accumulates behind the auricle.[1] With all this evidence, the authors provided a compelling argument regarding the inappropriate wearing of face masks could increase the risk of postoperative endophthalmitis. Nevertheless, we believe that there are a few important considerations that the authors may need to address before making such an assumption.
As a start, we ca...
We read with interest the manuscript published by Sakamoto et al, on behalf of the Japanese Retina and Vitreous Society, titled: Increased incidence of endophthalmitis after vitrectomy relative to face mask-wearing during COVID-19 pandemic”.[1] In this manuscript, the authors discuss their results after comparing the total prevalence of infectious endophthalmitis among patients that underwent ocular surgery, before and after the peak of the SARS-CoV-2 pandemic in Japan.[1] The authors should be commended due to the level of complexity and significant effort needed to coordinate several centers simultaneously, as well as the detailed description provided in the manuscript regarding the clinical presentation, microbiological results, and outcomes of all cases. Interestingly and despite the low rate of positive vitreous cultures, the authors were able to isolate oral bacteria among several of the cases that developed endophthalmitis during the pandemic, including one caused by Staphylococcus lugdunensis; a pathogen typically hard to eliminate with mechanical washing bacteria, because it accumulates behind the auricle.[1] With all this evidence, the authors provided a compelling argument regarding the inappropriate wearing of face masks could increase the risk of postoperative endophthalmitis. Nevertheless, we believe that there are a few important considerations that the authors may need to address before making such an assumption.
As a start, we can mention a few methodological irregularities that are hallmarks of any retrospective study and thus unavoidable. However, some may carry a significant relevance to the outcome such as the lack of rigor in the definition of postoperative endophthalmitis in the inclusion/exclusion criteria. In their manuscript, Sakamoto et al considered postoperative endophthalmitis, any intraocular infection that developed within 42 days after surgery. Although we agree with this definition, we must clarify that this definition refers to the maximum time elapsed between the invasion of the intraocular space by the offending bacteria, which is during surgery, and the development of the first clinical symptoms. Which, depending on the bacteria's virulence, could be up to 6 weeks. The latest optical coherence tomography and ultrasound biomicroscopy evidence have shown that sclerotomies after a pars plana vitrectomy seal between 8 and 15 days after surgery, even after a sutureless approach.[2 3] Therefore, it is highly unlikely that the source of infection originated after this time, as the authors seem to imply. Moreover, although the authors’ argument that face masking may increase the contamination of the periocular area makes sense, laboratory evidence has shown that there is no difference between bacterial dispersion toward the ocular surface when comparing different types of masks and masking techniques (tape in the superior border of the mask and no tape).[4] Nevertheless, we do agree that wearing a face mask before or during surgery may induce ocular surface changes such as dry eye disease and subclinical infectious keratitis, which might hypothetically increase the risk of endophthalmitis. If we consider the possible exhaustion of the surgical team (human error), scarcity of surgical disinfectants, and other factors that occurred during the peak of the SARS-CoV-2 pandemic, this should place the source of the infection during surgery and not after it. The high prevalence of Streptococcal endophthalmitis in the SARS-CoV-2 mask period (as defined by the authors), supports indeed the notion that contamination may come from the oral flora, very similar to the reports of post intravitreal injection endophthalmitis. However, bacteria such as Streptococcus mitis and Streptococcus salivarius are usually described as low-virulence or opportunistic pathogens. Therefore, the onset time of the clinical symptoms of endophthalmitis, information not described in the manuscript, could have helped the reader to infer if the contamination occurred during surgery or during the postoperative time.
Finally, the result observed regarding the prevalence of postoperative endophthalmitis in the only-phacoemulsification group, is not consistent with the main hypothesis suggested by the authors, and points in the opposite direction. If how the patient uses the mask during the postoperative period is indeed a determinant factor in endophthalmitis development and, considering that the prevalence of endophthalmitis after vitrectomy is usually lower in comparison to other surgical procedures [5]; we should have expected a proportional increase in the prevalence in all three groups. The latter might be the result of a lack of a sample calculation and therefore an error type 1, which should have been mentioned in the limitation section. A throughout analysis of the surgical circumstance per group is also lacking. Consequently, it is not clear at this time if other significant risk factors (trauma, intraocular foreign body, posterior capsule rupture) for endophthalmitis were present or not during surgery. A multivariate analysis, controlling for several other risk factors should be enough to shed light on this matter.
We congratulate Sakamoto et al for this outstanding contribution. We will look forward to their reply.
References:
1. Sakamoto T, Terasaki H, Yamashita T, et al. Increased incidence of endophthalmitis after vitrectomy relative to face mask wearing during COVID-19 pandemic. Br J Ophthalmol 2022 doi: 10.1136/bjophthalmol-2022-321357[published Online First: Epub Date]|.
2. Keshavamurthy R, Venkatesh P, Garg S. Ultrasound biomicroscopy findings of 25 G Transconjuctival Sutureless (TSV) and conventional (20G) pars plana sclerotomy in the same patient. BMC Ophthalmol 2006;6:7 doi: 10.1186/1471-2415-6-7[published Online First: Epub Date]|.
3. Sawada T, Kakinoki M, Sawada O, Kawamura H, Ohji M. Closure of sclerotomies after 25- and 23-gauge transconjunctival sutureless pars plana vitrectomy evaluated by optical coherence tomography. Ophthalmic Res 2011;45(3):122-8 doi: 10.1159/000318875[published Online First: Epub Date]|.
4. Angaramo S, Law JC, Maris AS, et al. Potential impact of oral flora dispersal on patients wearing face masks when undergoing ophthalmologic procedures. BMJ Open Ophthalmol 2021;6(1):e000804 doi: 10.1136/bmjophth-2021-000804[published Online First: Epub Date]|.
5. AlBloushi B, Mura M, Khandekar R, et al. Endophthalmitis Post Pars Plana Vitrectomy Surgery: Incidence, Organisms' Profile, and Management Outcome in a Tertiary Eye Hospital in Saudi Arabia. Middle East Afr J Ophthalmol 2021;28(1):1-5 doi: 10.4103/meajo.MEAJO_424_20[published Online First: Epub Date]|.
To the editor
We read the article published by Patel et al. with considerable interest [1]. The authors have provided interestingly novel insights into the prevalence and risk factors for chalazion. In their large case-control study comprising 3,453,944 older veteran participants with/without chalazion, the risk factors for chalazion included smoking, conditions of the tear film, conjunctivitis, dry eye, conditions affecting periocular skin, rosacea, allergic conditions, and systemic disorders, such as anxiety. Considering the relationship between chalazion and anxiety, a similar trend as reported in the previous study by Nemet et al. was observed [2]. Moreover, anxiety is generally considered as a psychological reaction to stress [3, 4]. Alsammahi et al. reported that stress is associated with the development of chalazion [5]. In real-world settings, we realize that patients with the onset of chalazion are likely to have anxiety or stress (such as work and examination).
Incidentally, in the c...
To the editor
We read the article published by Patel et al. with considerable interest [1]. The authors have provided interestingly novel insights into the prevalence and risk factors for chalazion. In their large case-control study comprising 3,453,944 older veteran participants with/without chalazion, the risk factors for chalazion included smoking, conditions of the tear film, conjunctivitis, dry eye, conditions affecting periocular skin, rosacea, allergic conditions, and systemic disorders, such as anxiety. Considering the relationship between chalazion and anxiety, a similar trend as reported in the previous study by Nemet et al. was observed [2]. Moreover, anxiety is generally considered as a psychological reaction to stress [3, 4]. Alsammahi et al. reported that stress is associated with the development of chalazion [5]. In real-world settings, we realize that patients with the onset of chalazion are likely to have anxiety or stress (such as work and examination).
Incidentally, in the coronavirus disease 2019 (COVID-19) pandemic era, Silkiss et al. reported that the incidence of chalazion increased with widespread mask wear, possibly resulting from eye dryness and changes in the eyelid microbiome associated with wearing face coverings [6]. Moreover, the widespread COVID-19 vaccinations provide many opportunities to examine the chalazion of patients who had recently received the vaccination at our institution, and most of these patients had anxiety or stress regarding the vaccination. To the best of our knowledge, the association between chalazion and COVID-19 vaccination has not been debated. Moreover, determining whether the chalazion occurred immediately after the vaccination was causation or coincidence is difficult because this disease is common and often observed in unvaccinated patients as well. However, we believe that these cases confirmed the result of Patel et al.’s study, wherein anxiety was associated with the risk of chalazion development. The need for vaccination against COVID-19 will continue because of the increased supply of COVID-19 vaccines for developing nations, recommendation of the third dose of vaccine, and the lowering of the age for vaccination against COVID-19, mainly in developed countries. Therefore, to elucidate the mechanism of chalazion after the vaccination, increasingly reliable care of this symptom following vaccination is warranted.
References
1. Patel S, Tohme N, Gorrin E, Kumar N, Goldhagen B, Galor A. Prevalence and risk factors for chalazion in an older veteran population. Br J Ophthalmol. 2021 Mar 31; bjophthalmol-2020-318420.
doi: 10.1136/bjophthalmol-2020-318420. Online ahead of print.
2. Nemet AY, Vinker S, Kaiserman I. Associated morbidity of chalazia. Cornea 2011; 30: 1376-1381.
3. Robinson L. Stress and anxiety. Nurs Clin North Am 1990; 25: 935-943.
4. American Psychological Association. Stress won’t go away? Maybe you are suffering from chronic stress. Available online: https://www.apa.org/topics/stress/chronic. Accessed March 15, 2022.
5. Alsammahi A, Aljohani Z, Jaad N, Daia OA, Aldayhum M, Almutairi M, Basendwah M, Alzahrani R, Alturki M. Incidence and predisposing factors of chalazion. Int J Community Med Public Health 2018; 5: 4979-4982.
6. Silkiss RZ, Paap MK, Ugradar S. Increased incidence of chalazion associated with face mask wear during the COVID-19 pandemic. Am J Ophthalmol Case Rep 2021; 22: 101032.
We read with interest the article by Sarker et al(1) in which they compared the outcomes of trabeculectomy versus Ahmed glaucoma valve (AGV) implantation in Sturge–Weber syndrome (SWS) patients with secondary glaucoma aged 11-62 years. As it noted in the paper, the authors found that complete success rates after 24 months were 80% and 70% in the AGV and trabeculectomy groups, respectively, and qualified success rates were 90% and 85% at same period in the AGV and trabeculectomy groups, respectively. We were delighted to get the conclusion that both AGV implant and trabeculectomy appeared to be safe and efficacious in controlling glaucoma secondary to SWS.
As it reported by Mohamed et al., the complete success rate and qualified success rate (intraocular pressure≤17mmHg) of trabeculectomy reported were 80% and 100% at 12 postoperative follow-up month, respectively(2). However, the qualified success rate (90%) of AGV implantation in SWS patients with secondary glaucoma is higher than that reported by Hamush et al. (79%)(3) and Kaushik et al. (76%)(4) at 2 years of follow-up. Meanwhile, the trabeculectomy with MMC success rate in this study was comparable to other studies about primary glaucoma(5, 6), but the success rate of tube shunt surgery was higher than in prior reports. The qualified success rate of Baerveldt implantation for patients who not had undergone previous incisional ocular surgery was 73% in Primary Tube Versus Trabeculectomy (PTVT) study(6) and 75% rep...
We read with interest the article by Sarker et al(1) in which they compared the outcomes of trabeculectomy versus Ahmed glaucoma valve (AGV) implantation in Sturge–Weber syndrome (SWS) patients with secondary glaucoma aged 11-62 years. As it noted in the paper, the authors found that complete success rates after 24 months were 80% and 70% in the AGV and trabeculectomy groups, respectively, and qualified success rates were 90% and 85% at same period in the AGV and trabeculectomy groups, respectively. We were delighted to get the conclusion that both AGV implant and trabeculectomy appeared to be safe and efficacious in controlling glaucoma secondary to SWS.
As it reported by Mohamed et al., the complete success rate and qualified success rate (intraocular pressure≤17mmHg) of trabeculectomy reported were 80% and 100% at 12 postoperative follow-up month, respectively(2). However, the qualified success rate (90%) of AGV implantation in SWS patients with secondary glaucoma is higher than that reported by Hamush et al. (79%)(3) and Kaushik et al. (76%)(4) at 2 years of follow-up. Meanwhile, the trabeculectomy with MMC success rate in this study was comparable to other studies about primary glaucoma(5, 6), but the success rate of tube shunt surgery was higher than in prior reports. The qualified success rate of Baerveldt implantation for patients who not had undergone previous incisional ocular surgery was 73% in Primary Tube Versus Trabeculectomy (PTVT) study(6) and 75% reported by Islamaj et al(5)at 2 years of follow-up. The qualified success rates of AGV implantation and Baerveldt implantation for patients with refractory glaucoma were 76% and 68% at 2 years of follow-up, respectively(7).
This more favorable result of AGV implantation relative to previous reports may because this small sample size study excluded 8 patients (16.7%), enrolled patients may uncomplete 2 years of review, or most of them are older than 18 years old compared with other study about SWS patients with secondary glaucoma(3, 4). The study enrolled eyes may at lower risk of surgical failure than that excluded from the study. As the authors mentioned, a total of 48 patients in glaucoma associated with SWS were surgically treated and 8 patients were excluded because of unreliable follow-ups and/or incomplete case records. Substantial differences in the success rate of cases with and without follow-up may overestimate the success rates of two surgeries and prove misleading on interpreting the results in this small sample size, retrospective study. What’s more, mean±SD follow-up in the study was 23.15±2.36 (range, 15–24) and 22.95±2.87 (range, 13–24) in the AGV and trabeculectomy groups, respectively, which may indicate incomplete 2 years of review for some patients. Patients who experienced successful surgical treatment at 15 months may subsequently experience treatment failure at 24 months. It’s better to supplement the number of patients at each follow up visit.
In conclusion, since the small sample size, it is better to supplement the outcomes of eight patients excluded from the study and the number of patients at each follow up visit so as to yield more convincing results.
Reference
1. Sarker BK, Malek MA, Mannaf SMA, Iftekhar QS, Mahatma M, Sarkar MK, et al. Outcome of trabeculectomy versus Ahmed glaucoma valve implantation in the surgical management of glaucoma in patients with Sturge-Weber syndrome. Br J Ophthalmol. 2021;105(11):1561-5.
2. Mohamed T, Salman A, Elshinawy R. Trabeculectomy with Ologen implant versus mitomycin C in congenital glaucoma secondary to Sturge Weber Syndrome. International journal of ophthalmology. 2018;11(2):251-5.
3. Hamush N, Coleman A, Wilson M. Ahmed glaucoma valve implant for management of glaucoma in Sturge-Weber syndrome. American journal of ophthalmology. 1999;128(6):758-60.
4. Kaushik J, Parihar J, Jain V, Mathur V. Ahmed valve implantation in childhood glaucoma associated with Sturge-Weber syndrome: our experience. Eye (London, England). 2019;33(3):464-8.
5. Islamaj E, Wubbels R, de Waard P. Primary baerveldt versus trabeculectomy study after 5 years of follow-up. Acta ophthalmologica. 2020;98(4):400-7.
6. Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, et al. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020;127(3):333-45.
7. Christakis P, Zhang D, Budenz D, Barton K, Tsai J, Ahmed I. Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study. American journal of ophthalmology. 2017;176:118-26.
Affiliations:
Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Division of Ophthalmology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA
Conflicts of Interest Disclosure:
APT: Consultant to Ivantis, Sandoz, and Zeiss
Acknowledgment:
APT is supported by an unrestricted departmental grant from Research to Prevent Blindness, NY, NY
Corresponding Author:
Angelo P. Tanna, M.D.
Department of Ophthalmology
Northwestern University Feinberg School of Medicine
645 N. Michigan Ave., Suite 440
Chicago, IL 60611
Telephone: 312-908-8152
Fax: 312-503-8152
E-mail: atanna@northwestern.edu
Dear Editor:
I read with interest the work of Doctor Hashimoto and colleagues on the risk of adverse neonatal outcomes (congenital anomalies, preterm birth, low birth weight) associated with maternal exposure to intraocular pressure-lowering medications during pregnancy.1 They used a large Japanese claims database and state-of-the-art statistical methodology to evaluate the frequency of adverse events in a cohort of live births of 91 women who had “at least one dispensation of IOP-lowering medications during the first trimester,” compared to that observed in 735 women with glaucoma or...
Affiliations:
Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Division of Ophthalmology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA
Conflicts of Interest Disclosure:
APT: Consultant to Ivantis, Sandoz, and Zeiss
Acknowledgment:
APT is supported by an unrestricted departmental grant from Research to Prevent Blindness, NY, NY
Corresponding Author:
Angelo P. Tanna, M.D.
Department of Ophthalmology
Northwestern University Feinberg School of Medicine
645 N. Michigan Ave., Suite 440
Chicago, IL 60611
Telephone: 312-908-8152
Fax: 312-503-8152
E-mail: atanna@northwestern.edu
Dear Editor:
I read with interest the work of Doctor Hashimoto and colleagues on the risk of adverse neonatal outcomes (congenital anomalies, preterm birth, low birth weight) associated with maternal exposure to intraocular pressure-lowering medications during pregnancy.1 They used a large Japanese claims database and state-of-the-art statistical methodology to evaluate the frequency of adverse events in a cohort of live births of 91 women who had “at least one dispensation of IOP-lowering medications during the first trimester,” compared to that observed in 735 women with glaucoma or suspicion of glaucoma who did not have such an exposure.
The authors discuss the previously used and outdated United States Food and Drug Administration (FDA) risk classification system for drugs used during pregnancy. The FDA required the removal of the pregnancy letter categories – A, B, C, D, and X from all drug product labels in 2015. Instead, for systemically absorbed drugs (which includes all ocular hypotensive medications), the FDA requires labeling to include a summary of the risks of using a drug during pregnancy as well as “risk statements based on data from all relevant sources (human, animal, and/or pharmacologic), that describe, for the drug, the risk of adverse developmental outcomes.”2
The investigators observed any adverse outcome in 17.6% of neonates with and in 13.3% without fetal exposure to IOP-lowering medications. The authors concluded that after propensity score adjustment, IOP-lowering medications were not significantly associated with more frequent adverse events. For example, the adjusted odds ratio for congenital anomalies was 1.43 (95% CI, 0.66 to 3.12).
The investigators only evaluated live births; therefore, the potentially increased risk of spontaneous abortion or fetal demise associated with the use of these agents during pregnancy cannot be known from this analysis. It is possible some of the women in the control cohort may have been exposed to ocular hypotensive agent(s) during the first trimester, using medication already in their possession, without necessarily having been dispensed any such agent during the first trimester. This could confound the comparative analysis.
Finally, the authors report their study had a power > 80% for detecting a two-fold increase in the composite outcome (i.e., the risk of any of the adverse neonatal outcomes studied). This begs the question: How much increased risk is a pregnant woman willing to accept? I believe a much lower threshold is necessary to arrive at a meaningful conclusion. In my experience, many women would reject even a 1% increase in the risk of a congenital anomaly. So then, the concluding message in the abstract that “IOP-lowering medications during the first trimester were not significantly associated with increase in congenital anomalies, preterm birth or low birth weight” is not meaningfully supported by the data. The study only supports the concept that the use of these medications is probably not associated with a doubling of the risk. Patients and society are interested in a higher threshold of safety.
Fortunately, pregnancy is often associated with a spontaneous reduction in intraocular pressure (IOP)4; therefore, continued treatment may not be required. Selective laser trabeculoplasty is also an option to consider for some patients. Moreover, many young patients with glaucoma can tolerate nine months of higher IOP.
Glaucoma in pregnancy is a complex problem that requires complex, collaborative decision-making. Pregnant women, their ophthalmologists and obstetricians must evaluate the potential risks associated with continued use of ocular hypotensive agents during pregnancy and weigh those against the risks of modifying or stopping therapy. I congratulate the authors on exploring this important topic and encourage others to conduct similar studies. Eventually, a meta-analysis may yield evidence that can guide clinical decision-making.
REFERENCES:
1. Hashimoto Y, Michihata N, Yamana H, Shigemi D, Morita K, Matsui H, Yasunaga H, Aihara M. Intraocular pressure-lowering medications during pregnancy and risk of neonatal adverse outcomes: a propensity score analysis using a large database. Br J Ophthalmol. 2021 Oct;105(10):1390-1394. doi: 10.1136/bjophthalmol-2020-316198. Epub 2020 Sep 9. PMID: 32907812.
2. Content and Format of Labeling for Human Prescription Drug and Biological Products;
Requirements for Pregnancy and Lactation Labeling. Department of Health and Human Services. Food and Drug Administration 21 CFR Part 201 [Docket No. FDA-2006-N-0515] RIN 0910-AF11. Available online at http://federalregister.gov/a/2014-28241.
3. Mezawa H, Tomotaki A, Yamamoto-Hanada K, Ishitsuka K, Ayabe T, Konishi M, Saito M, Yang L, Suganuma N, Hirahara F, Nakayama SF, Saito H, Ohya Y. Prevalence of Congenital Anomalies in the Japan Environment and Children's Study. J Epidemiol. 2019 Jul 5;29(7):247-256. doi: 10.2188/jea.JE20180014. Epub 2018 Sep 22. PMID: 30249945; PMCID: PMC6556438.
4. Ziai N, Ory SJ, Khan AR, Brubaker RF. Beta-human chorionic gonadotropin, progesterone, and aqueous dynamics during pregnancy. Arch Ophthalmol. 1994 Jun;112(6):801-6. doi: 10.1001/archopht.1994.01090180099043. PMID: 8002840.
Thank you for raising the issue of abbreviations entering the virological lexicon which might give rise to confusion and misunderstanding. Over a decade has elapsed since our patient report was published and the source material is not retrievable. However, our recollection is the patient was discussed contemporaneously at the MDT and the viral aetiology, radiology findings and medical management determined and documented, from which the data was sourced for the 2008 report. Plausible as it may seem, it is not possible to test the veracity of the suggestion that the names ‘Jamestown Canyon’ and ‘John Cunningham’ might have been transposed during that MDT many years after the event, paper records are not kept indefinitely in NHS practice and ethics in medical publishing demands that patient identifiers are not described or retained in order to preserve anonymity. Perhaps the latter should have been considered over half a century ago when JC virus was first identified in the brain of the unfortunate patient after whom the eponymous pathogen was christened
(Padgett BL, Walker DL; et al. (1971). "Cultivation of papova-like virus from human brain with progressive multifocal leucoencephalopathy". Lancet. 1 (7712):
1257–60. doi:10.1016/S0140-6736(71)91777-6)
I read with interest the article by Jonas et al 1. The main purpose of the authors was to explore associations between a disc size change and other morphological parameters. Indeed, many non-ophthalmic and game-changing parameters are associated with disc size change and other morphological parameters, such as the serum lipids 2 dietary factors (such as lutein, zeaxanthin, and omega-3 fatty acids) 2-4, medications (such as lipid-lowering agents) 2, genetic susceptibility, body mass index, age and sex 3, among which only age and sex are addressed in their retrospective analysis.
According to the authors, decrease in the ophthalmoscopic disc size in the myopic eyes during the 10-year follow up, is likely related to a shift of the Bruch’s membrane opening as the inner of the three optic nerve head canal layers into the direction of the fovea. While their interpretations can be partly true, their attributed mechanism is subject to many biases.
Firstly, changes in ophthalmoscopical optic disc size and Bruch’s membrane are a function of macular pigment optical density 5-7, which in turn is a function of dietary carotenoid intake 8;9. Tong et al 10 have shown before that macular pigment optical density (MPOD) is inversely associated with axial length in Chinese subjects with myopia, suggesting that carotenoid intake, particularly lutein, is associated to axial length as well. Another study with a smaller sample size (45 eyes of 32 patients) with a different mean a...
I read with interest the article by Jonas et al 1. The main purpose of the authors was to explore associations between a disc size change and other morphological parameters. Indeed, many non-ophthalmic and game-changing parameters are associated with disc size change and other morphological parameters, such as the serum lipids 2 dietary factors (such as lutein, zeaxanthin, and omega-3 fatty acids) 2-4, medications (such as lipid-lowering agents) 2, genetic susceptibility, body mass index, age and sex 3, among which only age and sex are addressed in their retrospective analysis.
According to the authors, decrease in the ophthalmoscopic disc size in the myopic eyes during the 10-year follow up, is likely related to a shift of the Bruch’s membrane opening as the inner of the three optic nerve head canal layers into the direction of the fovea. While their interpretations can be partly true, their attributed mechanism is subject to many biases.
Firstly, changes in ophthalmoscopical optic disc size and Bruch’s membrane are a function of macular pigment optical density 5-7, which in turn is a function of dietary carotenoid intake 8;9. Tong et al 10 have shown before that macular pigment optical density (MPOD) is inversely associated with axial length in Chinese subjects with myopia, suggesting that carotenoid intake, particularly lutein, is associated to axial length as well. Another study with a smaller sample size (45 eyes of 32 patients) with a different mean age did not show the same association 5. A detailed explanation of the reasons justifying these differences is provided elsewhere 11.
Secondly, in many medical situations (such as obesity, diabetes, etc.), MOPD is reduced dramatically 12;13. Jonas et al 1 report that only 89 highly myoptic eyes (i.e., 43.6%) were re-examined after 10 years. Although the authors report that the age of cases in 2011 did not differ significantly from the age of their controls in the survey of 2011, no other dietary or medical information is provided in their study. Thus, it is very difficult to draw a firm conclusion.
One can certainly question whether there were any changes in carotenoid intakes and/or any medical situation during a decade-long longitudinal study. In support of this argument, MOPD is reported to significantly increase within 3 months in healthy Japanese individuals supplemented with daily 10 mg of orally administered lutein or zeaxanthin 14. Interestingly, in high myopia, it has been shown that even after a shorter period of lutein supplementation (20 to 40 days), MPOD began to rise uniformly at an average rate of 1.13+/-0.12 milliabsorbance units/day. During this same period, the serum lutein concentration increased tenfold, and then approached a steady state plateau. Most critically, the optical density curve eventually levelled off some 40 to 50 days after the participants discontinued the supplement. Thus, even a modest period of dietary carotenoid intake may produce a 30 to 40% reduction in blue light reaching the photoreceptors, Bruch's membrane, and the retinal pigment epithelium 6.
Substantial differences are reported in terms of dietary carotenoid/lutein intake among Chinese population 15;16. This issue may be even more pronounced in a small sample size a low rate of re-participation.
We agree that geometrical reasons may lead to a decrease in the size of the ophthalmoscopically visible optic disc. However, their presumed mechanism 17 may simply be partially a byproduct of MOPD changes over time.
Reference List
1. Jonas JB, Zhang Q, Xu L et al. Change in the ophthalmoscopical optic disc size and shape in a 10-year follow-up: the Beijing Eye Study 2001-2011. Br.J Ophthalmol. 2021.
2. Renzi LM, Hammond BR, Jr., Dengler M et al. The relation between serum lipids and lutein and zeaxanthin in the serum and retina: results from cross-sectional, case-control and case study designs. Lipids Health Dis. 2012;11:33.
3. Bone RA, Landrum JT, Guerra LH et al. Lutein and zeaxanthin dietary supplements raise macular pigment density and serum concentrations of these carotenoids in humans. The Journal of nutrition 2003;133:992-8.
4. Lin KH, Tran T, Kim S et al. Advanced Retinal Imaging and Ocular Parameters of the Rhesus Macaque Eye. Transl.Vis.Sci Technol. 2021;10:7.
5. Benoudis L, Ingrand P, Jeau J et al. Relationships between macular pigment optical density and lacquer cracks in high myopia. J Fr.Ophtalmol. 2016;39:615-21.
6. Landrum JT, Bone RA, Joa H et al. A one year study of the macular pigment: the effect of 140 days of a lutein supplement. Exp.Eye Res. 1997;65:57-62.
7. Zarubina AV, Huisingh CE, Clark ME et al. Rod-Mediated Dark Adaptation and Macular Pigment Optical Density in Older Adults with Normal Maculas. Curr.Eye Res. 2018;43:913-20.
8. Ajana S, Weber D, Helmer C et al. Plasma Concentrations of Lutein and Zeaxanthin, Macular Pigment Optical Density, and Their Associations With Cognitive Performances Among Older Adults. Invest Ophthalmol.Vis.Sci 2018;59:1828-35.
9. Berendschot TT, Plat J, de JA et al. Long-term plant stanol and sterol ester-enriched functional food consumption, serum lutein/zeaxanthin concentration and macular pigment optical density. Br.J Nutr. 2009;101:1607-10.
10. Tong N, Zhang W, Zhang Z et al. Inverse relationship between macular pigment optical density and axial length in Chinese subjects with myopia. Graefes.Arch.Clin.Exp.Ophthalmol. 2013;251:1495-500.
11. Tong N, Zhang W, Wu X. Reply to the letter by Xing-Ru Zhang and Zhen-Yong Zhang: Comments on "Inverse relationship between macular pigment optical density and axial length in Chinese subjects with myopia". Graefes.Arch.Clin.Exp.Ophthalmol. 2013;251:2287.
12. Hammond BR, Jr., Ciulla TA, Snodderly DM. Macular pigment density is reduced in obese subjects. Invest Ophthalmol.Vis.Sci 2002;43:47-50.
13. Scanlon G, Connell P, Ratzlaff M et al. MACULAR PIGMENT OPTICAL DENSITY IS LOWER IN TYPE 2 DIABETES, COMPARED WITH TYPE 1 DIABETES AND NORMAL CONTROLS. Retina. 2015;35:1808-16.
14. Tanito M, Obana A, Gohto Y et al. Macular pigment density changes in Japanese individuals supplemented with lutein or zeaxanthin: quantification via resonance Raman spectrophotometry and autofluorescence imaging. Jpn.J Ophthalmol. 2012;56:488-96.
15. Ng ALK, Leung HH, Kawasaki R et al. Dietary habits, fatty acids and carotenoid levels are associated with neovascular age-related macular degeneration in Chinese. Nutrients 2019;11:1720.
16. Takata Y, Xiang YB, Yang G et al. Intakes of fruits, vegetables, and related vitamins and lung cancer risk: results from the Shanghai Men's Health Study (2002G_ô2009). Nutrition and cancer 2013;65:51-61.
17. Zhang Q, Xu L, Wei WB et al. Size and Shape of Bruch's Membrane Opening in Relationship to Axial Length, Gamma Zone, and Macular Bruch's Membrane Defects. Invest Ophthalmol.Vis.Sci 2019;60:2591-8.
In their 2008 case report, Muqit, et al. describe a case of “presumptive Jamestown Canyon viral retinitis.”1
Jamestown Canyon virus is a mosquito-borne, single-stranded, ribonucleic acid (RNA) orthobunyavirus that is endemic throughout much of North America.2,3 Infection with Jamestown Canyon virus may be asymptomatic or may result in a general febrile illness, meningitis, and/or meningoencephalitis.2,3 Beyond the above case report by Muqit, et al.,1 and another review article referencing this case report,4 Jamestown Canyon virus has not been reported to cause retinitis or other ocular manifestations.
Upon close review of the case report by Muqit, et al.,1 we believe the authors are likely describing a case of John Cunningham (JC) virus (a ubiquitous, double-stranded, deoxyribonucleic acid [DNA] human polyomavirus known to cause progressive multifocal leukoencephalopathy [PML] among the immunocompromised)5-7 rather than Jamestown Canyon virus.
First, the case patient with viral retinitis had underlying human immunodeficiency virus (HIV) infection and a low CD4 lymphocyte count (240 cells/mm3), making him immunocompromised and susceptible to reactivation of the John Cunningham (JC) virus. Second, the case patient had magnetic resonance imaging (MRI) brain findings (i.e., asymmetric, predominantly posterior, confluent, subcortical white matter hyperintensities involving U-fibers) that are classic for John Cunningham (JC) virus-related PML.6,7 In fact,...
In their 2008 case report, Muqit, et al. describe a case of “presumptive Jamestown Canyon viral retinitis.”1
Jamestown Canyon virus is a mosquito-borne, single-stranded, ribonucleic acid (RNA) orthobunyavirus that is endemic throughout much of North America.2,3 Infection with Jamestown Canyon virus may be asymptomatic or may result in a general febrile illness, meningitis, and/or meningoencephalitis.2,3 Beyond the above case report by Muqit, et al.,1 and another review article referencing this case report,4 Jamestown Canyon virus has not been reported to cause retinitis or other ocular manifestations.
Upon close review of the case report by Muqit, et al.,1 we believe the authors are likely describing a case of John Cunningham (JC) virus (a ubiquitous, double-stranded, deoxyribonucleic acid [DNA] human polyomavirus known to cause progressive multifocal leukoencephalopathy [PML] among the immunocompromised)5-7 rather than Jamestown Canyon virus.
First, the case patient with viral retinitis had underlying human immunodeficiency virus (HIV) infection and a low CD4 lymphocyte count (240 cells/mm3), making him immunocompromised and susceptible to reactivation of the John Cunningham (JC) virus. Second, the case patient had magnetic resonance imaging (MRI) brain findings (i.e., asymmetric, predominantly posterior, confluent, subcortical white matter hyperintensities involving U-fibers) that are classic for John Cunningham (JC) virus-related PML.6,7 In fact, the authors claimed that the MRI brain findings were “confirmatory of the underlying diagnosis.”1 No MRI brain findings are classic or confirmatory for Jamestown Canyon virus infection. Third, the case patient’s cerebrospinal fluid was reportedly positive for viral DNA by polymerase chain reaction. This could only be possible for a DNA virus (i.e., John Cunningham (JC) virus) and not an RNA virus (i.e., Jamestown Canyon virus). Fourth, recovery of John Cunningham (JC) viral nucleic acid from ocular tissues of HIV-infected patients has been previously reported, so there is already precedent for this virus to infect the eye.8 Finally, the case patient had no known travel to or any mosquito exposure in North America, where Jamestown Canyon virus is endemic.2,3
Given John Cunningham (JC) and Jamestown Canyon viruses have different virology, epidemiology, and clinical manifestations, we believe the viruses were mistaken for one another because they share the same first letters of their words (i.e., J and C) and their abbreviations were likely confused. If our suspicion is correct, this case report highlights the possible dangers of abbreviations in medicine and the need to clearly define potentially confusing abbreviations in medical literature.
References
1. Muqit MM, Devonport H, Smith RA, Dhillon B. Presumptive Jamestown Canyon viral retinitis. Br J Ophthalmol. 2008 Dec;92(12):1599-600, 1695-6. doi: 10.1136/bjo.2007.132902. PMID: 19029162.
2. Coleman KJ, Chauhan L, Piquet AL, Tyler KL, Pastula DM. An Overview of Jamestown Canyon Virus Disease. Neurohospitalist. 2021 Jul;11(3):277-278. doi: 10.1177/19418744211005948. Epub 2021 Mar 29. PMID: 34163560; PMCID: PMC8182404.
3. Pastula DM, Hoang Johnson DK, White JL, Dupuis AP 2nd, Fischer M, Staples JE. Jamestown Canyon Virus Disease in the United States-2000-2013. Am J Trop Med Hyg. 2015 Aug;93(2):384-9. doi: 10.4269/ajtmh.15-0196. Epub 2015 Jun 1. PMID: 26033022; PMCID: PMC4530766.
4. Karesh JW, Mazzoli RA, Heintz SK. Ocular Manifestations of Mosquito-Transmitted Diseases. Mil Med. 2018 Mar 1;183(suppl_1):450-458. doi: 10.1093/milmed/usx183. PMID: 29635625.
5. Padgett BL, Walker DL, ZuRhein GM, Eckroade RJ, Dessel BH. Cultivation of papova-like virus from human brain with progressive multifocal leucoencephalopathy. Lancet. 1971 Jun 19;1(7712):1257-60. doi: 10.1016/s0140-6736(71)91777-6. PMID: 4104715.
6. Grebenciucova E, Berger JR. Progressive Multifocal Leukoencephalopathy. Neurol Clin. 2018 Nov;36(4):739-750. doi: 10.1016/j.ncl.2018.06.002. PMID: 30366552.
7. Pinto M, Dobson S. BK and JC virus: a review. J Infect. 2014 Jan;68 Suppl 1:S2-8. doi: 10.1016/j.jinf.2013.09.009. Epub 2013 Oct 8. PMID: 24119828.
8. Eberwein P, Hansen LL, Agostini HT. Genotypes of JC virus, DNA of cytomegalovirus, and proviral DNA of human immunodeficiency virus in eyes of acquired immunodeficiency syndrome patients. J Neurovirol. 2005 Feb;11(1):58-65. doi: 10.1080/13550280590900391. PMID: 15804960.
We read with great interest the article by Forte et al1, "Swept source optical Coherence tomography Angiography in patients treated with hydroxychloroquine: co-relation of the functional and morphological test." Hydroxychloroquine (HCQ) is a widely used drug for the management of systemic lupus erythematosus and rheumatoid arthritis. Non-invasive tests like optical coherence tomography, optical coherence tomography-angiography, 10-2 visual fields and multifocal ERG (mf-ERG) help in the early detection of the toxicity.2 We would like to highlight here importance of adaptive optics, and various studies done for the early detection of HCQ toxicity. In the study by Forte et al, mf-ERG did not co-relate with the flow changes on OCT-A, however in another observation by Penrose et al (n=6) a depression of signals on multifocal ERG was found in the perifoveal region even when the patients had normal visual acuity and a normal fundus.3Costa et al found significant differences between the micro-perimetry in the patients taking hydroxychloroquine and controls.4 It will be interesting to know the authors take on this. Besides these, adaptive optics is emerging as an important tool to detect the early photo-receptor changes in patients with HCQ toxicity. Adaptive optics help in the direct visualization of the cone mosaic. Stepien et al in their observation on 4 patients observed that adaptive optics showed a loss of cone mosaic in the perifoveal region that corresponded with...
We read with great interest the article by Forte et al1, "Swept source optical Coherence tomography Angiography in patients treated with hydroxychloroquine: co-relation of the functional and morphological test." Hydroxychloroquine (HCQ) is a widely used drug for the management of systemic lupus erythematosus and rheumatoid arthritis. Non-invasive tests like optical coherence tomography, optical coherence tomography-angiography, 10-2 visual fields and multifocal ERG (mf-ERG) help in the early detection of the toxicity.2 We would like to highlight here importance of adaptive optics, and various studies done for the early detection of HCQ toxicity. In the study by Forte et al, mf-ERG did not co-relate with the flow changes on OCT-A, however in another observation by Penrose et al (n=6) a depression of signals on multifocal ERG was found in the perifoveal region even when the patients had normal visual acuity and a normal fundus.3Costa et al found significant differences between the micro-perimetry in the patients taking hydroxychloroquine and controls.4 It will be interesting to know the authors take on this. Besides these, adaptive optics is emerging as an important tool to detect the early photo-receptor changes in patients with HCQ toxicity. Adaptive optics help in the direct visualization of the cone mosaic. Stepien et al in their observation on 4 patients observed that adaptive optics showed a loss of cone mosaic in the perifoveal region that corresponded with the OCT findings. OCT findings in their study showed a loss of IS -OS junction with preservation of retinal pigment epithelium and external limiting membrane showing a "sinking hole defect". SD-OCT and adaptive optics also showed defects in the area which were unaffected on 10-2 perimetry, suggesting pre-clinical loss. 5 Similarly, Debellemanière G et al, in their study on eyes found that there was increased cone spacing and moderate cone loss with an increasing cumulative dose of HCQ.6 It will be interesting to know the author's point of view about this, Thus to conclude, the non-invasive investigations may aid in the early detection of HCQ toxicity.
References
1. Forte R, Haulani H, Dyrda A, et al
Swept source optical coherence tomography angiography in patients treated with hydroxychloroquine: correlation with morphological and functional tests. British Journal of Ophthalmology 2021;105:1297-1301.
2. Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF; American Academy of Ophthalmology. Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). Ophthalmology. 2016 Jun;123(6):1386-94
3. Penrose PJ, Tzekov RT, Sutter EE, Fu AD, Allen AW Jr, Fung WE, Oxford KW. Multifocal electroretinography evaluation for early detection of retinal dysfunction in patients taking hydroxychloroquine. Retina. 2003 Aug;23(4):503-12.
4. Martínez-Costa L, Victoria Ibañez M, Murcia-Bello C, Epifanio I, Verdejo-Gimeno C, Beltrán-Catalán E, Marco-Ventura P. Use of microperimetry to evaluate hydroxychloroquine and chloroquine retinal toxicity. Can J Ophthalmol. 2013 Oct;48(5):400-5. doi: 10.1016/j.jcjo.2013.03.018. PMID: 24093187.
5. Stepien KE, Han DP, Schell J, Godara P, Rha J, Carroll J. Spectral-domain optical coherence tomography and adaptive optics may detect hydroxychloroquine retinal toxicity before symptomatic vision loss. Trans Am Ophthalmol Soc. 2009 Dec;107:28-33. PMID: 20126479; PMCID: PMC2814561.
6. Debellemanière G, Flores M, Tumahai P, Meillat M, Bidaut Garnier M, Delbosc B, Saleh M. Assessment of parafoveal cone density in patients taking hydroxychloroquine in the absence of clinically documented retinal toxicity. Acta Ophthalmol. 2015 Nov;93(7):e534-40
Shang et al. conducted a prospective study to examine the effect of ophthalmic and systemic conditions on incident dementia (1). The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of age-related macular degeneration (AMD), cataract, diabetes-related eye disease (DRED), and glaucoma at baseline for incident dementia were 1.26 (1.05 to 1.52), 1.11 (1.00 to 1.24), 1.61 (1.30 to 2.00), and 1.07 (0.92 to 1.25), respectively. Diabetes, heart disease, stroke and depression at baseline were also significantly associated with an increased risk of dementia. In addition, some combinations of ophthalmic and systemic conditions were at the higher risk for incident dementia. I have a comment about the study.
Vision impairment is a risk factor of dementia, and poor vision is independently associated with a decline in cognitive function (2). Shang et al. clarified that AMD, cataract, and DRED were risk of incident dementia, and some combinations with systemic conditions accelerated risk of incident dementia. Although glaucoma was not significantly associated with increased risk of al-cause dementia, it was significantly associated with increased risk of vascular dementia. The authors also conducted analysis by excluding data in the first 5 years of follow-up, consistent results were also specified on the combined effects of ophthalmic and systemic conditions on incident dementia. Although the mechanism of increased risk of dementia in combinations with ophthalmic and...
Shang et al. conducted a prospective study to examine the effect of ophthalmic and systemic conditions on incident dementia (1). The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of age-related macular degeneration (AMD), cataract, diabetes-related eye disease (DRED), and glaucoma at baseline for incident dementia were 1.26 (1.05 to 1.52), 1.11 (1.00 to 1.24), 1.61 (1.30 to 2.00), and 1.07 (0.92 to 1.25), respectively. Diabetes, heart disease, stroke and depression at baseline were also significantly associated with an increased risk of dementia. In addition, some combinations of ophthalmic and systemic conditions were at the higher risk for incident dementia. I have a comment about the study.
Vision impairment is a risk factor of dementia, and poor vision is independently associated with a decline in cognitive function (2). Shang et al. clarified that AMD, cataract, and DRED were risk of incident dementia, and some combinations with systemic conditions accelerated risk of incident dementia. Although glaucoma was not significantly associated with increased risk of al-cause dementia, it was significantly associated with increased risk of vascular dementia. The authors also conducted analysis by excluding data in the first 5 years of follow-up, consistent results were also specified on the combined effects of ophthalmic and systemic conditions on incident dementia. Although the mechanism of increased risk of dementia in combinations with ophthalmic and systemic conditions might be difficult to be explained, medical care on both ophthalmic and systemic conditions will be indispensable to avid acceleration of cognitive decline.
References
1. Shang X, Zhu Z, Huang Y, et al. Associations of ophthalmic and systemic conditions with incident dementia in the UK Biobank. Br J Ophthalmol 2021 Sep 13. doi: 10.1136/bjophthalmol-2021-319508
2. Lim ZW, Chee ML, Soh ZD, et al. Association Between Visual Impairment and Decline in Cognitive Function in a Multiethnic Asian Population. JAMA Netw Open 2020;3(4):e203560.
Randomized controlled trials (RCTs) are considered to be the best method for evaluating the effectiveness of medical interventions.1 Despite their strengths, RCTs have substantial limitations.1 Although RCTs have strong internal validity, they occasionally lack external validity and generalizations of findings outside the study population may be invalid. More specifically in retinal surgery, there are many obstacles to conducting RCTs to address the specific questions asked, so the analysis using real-world data is useful.2 Drs Anguita and Charteris wrote an editorial in the British Journal of Ophthalmology (BJO) on the merits and limitations of studies using real-world data.3 They cited our papers that were recently published in BJO which used the data collected in the Japan Retinal Detachment Registry (J-RD registry), and I would like to comment on with a focus on the retinal surgery.4,5
As correctly stated by Drs Anguita and Charteris, studies using the propensity score matching method cannot be performed well if one is not familiar with the limitations of this technique. 3 However, this is also true for those who do not have a deep understanding of the disease and may make incorrect interpretations. This would be the case for our paper4 cited in the editorial. This study compared pars plana vitrectomy (PPV) and scleral buckling for superior RD without macula detachment using the data from the J-RD registry. The results which were analyzed using propensity score...
Show MoreDear Editor.
We read with interest the manuscript published by Sakamoto et al, on behalf of the Japanese Retina and Vitreous Society, titled: Increased incidence of endophthalmitis after vitrectomy relative to face mask-wearing during COVID-19 pandemic”.[1] In this manuscript, the authors discuss their results after comparing the total prevalence of infectious endophthalmitis among patients that underwent ocular surgery, before and after the peak of the SARS-CoV-2 pandemic in Japan.[1] The authors should be commended due to the level of complexity and significant effort needed to coordinate several centers simultaneously, as well as the detailed description provided in the manuscript regarding the clinical presentation, microbiological results, and outcomes of all cases. Interestingly and despite the low rate of positive vitreous cultures, the authors were able to isolate oral bacteria among several of the cases that developed endophthalmitis during the pandemic, including one caused by Staphylococcus lugdunensis; a pathogen typically hard to eliminate with mechanical washing bacteria, because it accumulates behind the auricle.[1] With all this evidence, the authors provided a compelling argument regarding the inappropriate wearing of face masks could increase the risk of postoperative endophthalmitis. Nevertheless, we believe that there are a few important considerations that the authors may need to address before making such an assumption.
Show MoreAs a start, we ca...
Clinical features of chalazion following COVID-19 vaccination
Yusuke Kameda, Megumi Sugai, Karin Ishinabe, Nichika Fukuoka
Yotsuya-sanchome Ekimae Eye Clinic, Tokyo, Japan
*Corresponding author: Yusuke Kameda, MD, Yotsuya-sanchome Ekimae Eye Clinic, Tokyo, Japan, 3-7-24 Yotsuya, Shinjuku-ku Tokyo 160-0004, Japan.
Phone: 81-3-6380-4101; Fax: 81-3-6380-4133; E-mail: y09025618059@leaf.ocn.ne.jp
To the editor
Show MoreWe read the article published by Patel et al. with considerable interest [1]. The authors have provided interestingly novel insights into the prevalence and risk factors for chalazion. In their large case-control study comprising 3,453,944 older veteran participants with/without chalazion, the risk factors for chalazion included smoking, conditions of the tear film, conjunctivitis, dry eye, conditions affecting periocular skin, rosacea, allergic conditions, and systemic disorders, such as anxiety. Considering the relationship between chalazion and anxiety, a similar trend as reported in the previous study by Nemet et al. was observed [2]. Moreover, anxiety is generally considered as a psychological reaction to stress [3, 4]. Alsammahi et al. reported that stress is associated with the development of chalazion [5]. In real-world settings, we realize that patients with the onset of chalazion are likely to have anxiety or stress (such as work and examination).
Incidentally, in the c...
We read with interest the article by Sarker et al(1) in which they compared the outcomes of trabeculectomy versus Ahmed glaucoma valve (AGV) implantation in Sturge–Weber syndrome (SWS) patients with secondary glaucoma aged 11-62 years. As it noted in the paper, the authors found that complete success rates after 24 months were 80% and 70% in the AGV and trabeculectomy groups, respectively, and qualified success rates were 90% and 85% at same period in the AGV and trabeculectomy groups, respectively. We were delighted to get the conclusion that both AGV implant and trabeculectomy appeared to be safe and efficacious in controlling glaucoma secondary to SWS.
Show MoreAs it reported by Mohamed et al., the complete success rate and qualified success rate (intraocular pressure≤17mmHg) of trabeculectomy reported were 80% and 100% at 12 postoperative follow-up month, respectively(2). However, the qualified success rate (90%) of AGV implantation in SWS patients with secondary glaucoma is higher than that reported by Hamush et al. (79%)(3) and Kaushik et al. (76%)(4) at 2 years of follow-up. Meanwhile, the trabeculectomy with MMC success rate in this study was comparable to other studies about primary glaucoma(5, 6), but the success rate of tube shunt surgery was higher than in prior reports. The qualified success rate of Baerveldt implantation for patients who not had undergone previous incisional ocular surgery was 73% in Primary Tube Versus Trabeculectomy (PTVT) study(6) and 75% rep...
Title: Management of Glaucoma During Pregnancy
Author: Angelo P. Tanna
Affiliations:
Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Division of Ophthalmology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA
Conflicts of Interest Disclosure:
APT: Consultant to Ivantis, Sandoz, and Zeiss
Acknowledgment:
APT is supported by an unrestricted departmental grant from Research to Prevent Blindness, NY, NY
Corresponding Author:
Angelo P. Tanna, M.D.
Department of Ophthalmology
Northwestern University Feinberg School of Medicine
645 N. Michigan Ave., Suite 440
Chicago, IL 60611
Telephone: 312-908-8152
Fax: 312-503-8152
E-mail: atanna@northwestern.edu
Dear Editor:
I read with interest the work of Doctor Hashimoto and colleagues on the risk of adverse neonatal outcomes (congenital anomalies, preterm birth, low birth weight) associated with maternal exposure to intraocular pressure-lowering medications during pregnancy.1 They used a large Japanese claims database and state-of-the-art statistical methodology to evaluate the frequency of adverse events in a cohort of live births of 91 women who had “at least one dispensation of IOP-lowering medications during the first trimester,” compared to that observed in 735 women with glaucoma or...
Show MoreThank you for raising the issue of abbreviations entering the virological lexicon which might give rise to confusion and misunderstanding. Over a decade has elapsed since our patient report was published and the source material is not retrievable. However, our recollection is the patient was discussed contemporaneously at the MDT and the viral aetiology, radiology findings and medical management determined and documented, from which the data was sourced for the 2008 report. Plausible as it may seem, it is not possible to test the veracity of the suggestion that the names ‘Jamestown Canyon’ and ‘John Cunningham’ might have been transposed during that MDT many years after the event, paper records are not kept indefinitely in NHS practice and ethics in medical publishing demands that patient identifiers are not described or retained in order to preserve anonymity. Perhaps the latter should have been considered over half a century ago when JC virus was first identified in the brain of the unfortunate patient after whom the eponymous pathogen was christened
(Padgett BL, Walker DL; et al. (1971). "Cultivation of papova-like virus from human brain with progressive multifocal leucoencephalopathy". Lancet. 1 (7712):
1257–60. doi:10.1016/S0140-6736(71)91777-6)
I read with interest the article by Jonas et al 1. The main purpose of the authors was to explore associations between a disc size change and other morphological parameters. Indeed, many non-ophthalmic and game-changing parameters are associated with disc size change and other morphological parameters, such as the serum lipids 2 dietary factors (such as lutein, zeaxanthin, and omega-3 fatty acids) 2-4, medications (such as lipid-lowering agents) 2, genetic susceptibility, body mass index, age and sex 3, among which only age and sex are addressed in their retrospective analysis.
According to the authors, decrease in the ophthalmoscopic disc size in the myopic eyes during the 10-year follow up, is likely related to a shift of the Bruch’s membrane opening as the inner of the three optic nerve head canal layers into the direction of the fovea. While their interpretations can be partly true, their attributed mechanism is subject to many biases.
Firstly, changes in ophthalmoscopical optic disc size and Bruch’s membrane are a function of macular pigment optical density 5-7, which in turn is a function of dietary carotenoid intake 8;9. Tong et al 10 have shown before that macular pigment optical density (MPOD) is inversely associated with axial length in Chinese subjects with myopia, suggesting that carotenoid intake, particularly lutein, is associated to axial length as well. Another study with a smaller sample size (45 eyes of 32 patients) with a different mean a...
Show MoreIn their 2008 case report, Muqit, et al. describe a case of “presumptive Jamestown Canyon viral retinitis.”1
Jamestown Canyon virus is a mosquito-borne, single-stranded, ribonucleic acid (RNA) orthobunyavirus that is endemic throughout much of North America.2,3 Infection with Jamestown Canyon virus may be asymptomatic or may result in a general febrile illness, meningitis, and/or meningoencephalitis.2,3 Beyond the above case report by Muqit, et al.,1 and another review article referencing this case report,4 Jamestown Canyon virus has not been reported to cause retinitis or other ocular manifestations.
Upon close review of the case report by Muqit, et al.,1 we believe the authors are likely describing a case of John Cunningham (JC) virus (a ubiquitous, double-stranded, deoxyribonucleic acid [DNA] human polyomavirus known to cause progressive multifocal leukoencephalopathy [PML] among the immunocompromised)5-7 rather than Jamestown Canyon virus.
First, the case patient with viral retinitis had underlying human immunodeficiency virus (HIV) infection and a low CD4 lymphocyte count (240 cells/mm3), making him immunocompromised and susceptible to reactivation of the John Cunningham (JC) virus. Second, the case patient had magnetic resonance imaging (MRI) brain findings (i.e., asymmetric, predominantly posterior, confluent, subcortical white matter hyperintensities involving U-fibers) that are classic for John Cunningham (JC) virus-related PML.6,7 In fact,...
Show MoreWe read with great interest the article by Forte et al1, "Swept source optical Coherence tomography Angiography in patients treated with hydroxychloroquine: co-relation of the functional and morphological test." Hydroxychloroquine (HCQ) is a widely used drug for the management of systemic lupus erythematosus and rheumatoid arthritis. Non-invasive tests like optical coherence tomography, optical coherence tomography-angiography, 10-2 visual fields and multifocal ERG (mf-ERG) help in the early detection of the toxicity.2 We would like to highlight here importance of adaptive optics, and various studies done for the early detection of HCQ toxicity. In the study by Forte et al, mf-ERG did not co-relate with the flow changes on OCT-A, however in another observation by Penrose et al (n=6) a depression of signals on multifocal ERG was found in the perifoveal region even when the patients had normal visual acuity and a normal fundus.3Costa et al found significant differences between the micro-perimetry in the patients taking hydroxychloroquine and controls.4 It will be interesting to know the authors take on this. Besides these, adaptive optics is emerging as an important tool to detect the early photo-receptor changes in patients with HCQ toxicity. Adaptive optics help in the direct visualization of the cone mosaic. Stepien et al in their observation on 4 patients observed that adaptive optics showed a loss of cone mosaic in the perifoveal region that corresponded with...
Show MoreShang et al. conducted a prospective study to examine the effect of ophthalmic and systemic conditions on incident dementia (1). The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of age-related macular degeneration (AMD), cataract, diabetes-related eye disease (DRED), and glaucoma at baseline for incident dementia were 1.26 (1.05 to 1.52), 1.11 (1.00 to 1.24), 1.61 (1.30 to 2.00), and 1.07 (0.92 to 1.25), respectively. Diabetes, heart disease, stroke and depression at baseline were also significantly associated with an increased risk of dementia. In addition, some combinations of ophthalmic and systemic conditions were at the higher risk for incident dementia. I have a comment about the study.
Vision impairment is a risk factor of dementia, and poor vision is independently associated with a decline in cognitive function (2). Shang et al. clarified that AMD, cataract, and DRED were risk of incident dementia, and some combinations with systemic conditions accelerated risk of incident dementia. Although glaucoma was not significantly associated with increased risk of al-cause dementia, it was significantly associated with increased risk of vascular dementia. The authors also conducted analysis by excluding data in the first 5 years of follow-up, consistent results were also specified on the combined effects of ophthalmic and systemic conditions on incident dementia. Although the mechanism of increased risk of dementia in combinations with ophthalmic and...
Show MorePages