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Recent eLetters

Displaying 1-10 letters out of 463 published

  1. Quantifying Symptomatology in Convergence Insufficiency Using the Convergence Insufficiency Symptom Survey

    We are in agreement with Horwood and associates that the Convergence Insufficiency Symptom Survey (CISS) was not designed as a screening tool for convergence insufficiency (CI) and thus should not be used as such. However, we would like to point out that their conclusion from their recent paper(1) that the "majority of subjects with clinical signs of CI (reduced convergence and fusional ranges) have no symptoms," is not supported by their data. Unfortunately, their study design severely limits any conclusions that can be made regarding symptoms in young adults with CI because 1) the study specifically recruited "asymptomatic" subjects, 2) the study excluded subjects who would clearly meet the clinical diagnosis of CI, and 3) the CISS was not administered as designed and validated.

    In regards to subject selection, only university students "who considered their eyes normal" and had not sought treatment for visual symptoms in the past were invited to participate. They were asked to complete the CISS to "confirm the absence of significant visual symptoms" during the recruitment phase of another study for which they were to be paid. There is little doubt that eliminating students with visually- related symptoms and those who had been informed in the past about a binocular vision anomaly (including CI) and associated symptoms, resulted in significant selection bias for a study evaluating the presence of symptoms in those with and without CI.

    Another troublesome issue is that those with a near exophoria greater than 8 prism diopters (pd) were excluded, meaning that none of those diagnosed with CI had a large exophoria at near. We are perplexed why a patient with a near exophoria of 10 pd, a receded near point of convergence, and poor convergence amplitudes at near would be excluded from a study of CI. A high exophoria at near is usually considered to be one of the hallmark clinical signs of CI (2-4) For example, in a CITT study of young adults with symptomatic CI the mean near exophoria was 10.6 (SD=4.8).(5)

    Of further concern is that rather than administering the CISS as designed and validated, the authors administered the CISS using a non- standard testing approach. The survey was emailed to students who were told that the purpose was to "confirm the absence of significant visual symptoms in a quantifiable fashion." In addition, supplemental questions (e.g., "Do you think it was because you were tired at the time?" or "Do you think it was because your eyes have made it necessary?") were added for 5 of the 15 survey items and adjusted scores were derived. Apparently, the authors assumed that the students could distinguish whether their symptoms were directly related to their visual system and that altering the presentation of CISS questions would not impact the validity of the instrument. Certainly, a golden rule when administering a validated questionnaire is that it should not be modified because even very small changes can negatively impact its validity. As emphasized by E. Juniper, "it is beholden to each one of us to ensure that we use only authorized versions in our clinical practice and research."(6) The only way to know with any certainty if a questionnaire can be improved with modifications is if the validity and reliability are established for the modified version. Lastly, we are disappointed that the authors presented their modified version in their Figure 1 as the "convergence insufficiency symptom survey" when it is obviously not the copyrighted version of the test. This is bound to lead to confusion for readers, especially those who are unfamiliar with the CISS.

    As correctly noted by the authors, the CISS was developed as a method of quantifying and monitoring symptoms in persons with CI; it was never intended, nor have we promoted it to be used as a screening instrument for CI. However, the presence of symptoms associated with reading is often the critical factor used when optometrists and ophthalmologists recommend treatment for CI. If the CISS is administered and scored as designed, it can be a useful tool for "quantifying" symptoms in children and adults with CI before and after treatment in clinical studies or in clinical practice. The answer to the question of what proportion of university students with CI are symptomatic remains unanswered.

    1. Horwood AM, Toor S, Riddell PM. Screening for convergence insufficiency using the CISS is not indicated in young adults. Br J Ophthalmol. 2014;98(5):679-83.

    2. Convergence Insufficiency Treatment Trial (CITT) Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008;126:1336-49.

    3. Dusek WA, Pierscionek BK, McClelland JF. An evaluation of clinical treatment of convergence insufficiency for children with reading difficulties. BMC Ophthalmol. 2011;11:21.

    4. Scheiman M, Gwiazda J, T L. Non-surgical interventions for convergence insufficiency. Cochrane Database of Systematic Reviews 2011(Issue 3. Art.No.: CD006768. DOI: 10.1002/14651858.CD006768.pub2.).

    5. Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, et al. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004;24(5):384-90.

    6. Juniper EF. Validated questionnaires should not be modified. Eur Respir J. 2009;34(5):1015-7.

    Conflict of Interest:

    None declared

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  2. Recent trends in glaucoma surgery, accurately assessed? - A case for updated coding?

    We read with interest the recent article by Murphy, et al*. The authors report a six-fold increase in the use of glaucoma drainage devices (GDDs) between 2003 and 2012. They also note that non-penetrating glaucoma surgery (NPGS) and minimally-invasive glaucoma surgery (MIGS) were not analyzed due to the small numbers being undertaken. One confounder is MIGS have the same code as for GDDs & have been in the UK since 2009. Consequently, the analysis and conclusions in the paper may be inaccurate. The manufacturers of MIGS devices were asked if they knew of any other codes being used, to which they responded, "No." The increase in numbers of GDDs in paediatric populations is most likely accurate. However, this may not reflect adult surgery.

    It is hard to support the authors' comment that the number of NPGS is small. Several newly-appointed Consultant Glaucoma Surgeons perform NPGS; it is offered as part of subspecialty training in certain centres, thereby cascading the likelihood the procedure is performed. There is no clear code for NPGS, hence it is hard to know how many NPGS are actually being performed. A poll of UK surgeons undertaking NPGS found that 3-4000 procedures were undertaken during the timescale of the Murphy study. Six recently appointed Consultants reported having performed approximately 700 last year. These are not small numbers. It is unfortunate they cannot be extracted from the overall number of procedures. We also thought it was interesting there was no mention of trabeculotomy or goniotomy in the paediatric group. Trabeculotomy is the most common procedure for childhood glaucomas in the United States and GDDs would be used if these failed.

    Whilst the authors are to be congratulated on an interesting review, an update of the OPCS codes may help us obtain more meaningful data in the future.

    * Murphy C, Ogston S, Cobb C, et al. Recent trends in glaucoma surgery in Scotland, England and Wales Br J Ophthalmology. Published Online First 10 September 2014

    Conflict of Interest:

    None declared

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  3. Details of participants in the study are incomplete.

    I have read the article with great interest as it is one of the early reports of this emerging technology. Going through the article I noticed that though the inclusion criteria describe that the patients with refractive error less than 10 diopter of myopia and astigmatism less than 5 diopter were included, the results show only the average myopia and standard deviation. The range of spherical myopia is not given, though the range of astigmatism is provided.

    i will be keen to know the range of myopia included as it is obvious that a very thin lenticule will be difficult to create and retrieve in case of low myopia.

    Kindly comment on the following points, 1. the range of myopic refractive error included in the study. 2. Any limitation in including patients with low myopia. 3. Was there any difficulty in handling a thin lenticule in the patients with low refractive error?

    Conflict of Interest:

    None declared

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  4. Dua's Layer and Success of Non Penetrating Glaucoma Filtering surgery

    Dear Editor,

    We read with interest the article on extension of Dua's layer into trabecular meshwork.(1)This knowledge has implications also in success of newer surgeries like deep sclerectomy. Deep Sclerectomy is a safer option to trabeculectomy but is known to fail in some cases (2)(3). Guedes et al(4) have investigated the factors affecting the success of this surgery. George Kistos et al (5) have discussed a modified deep sclerectomy to deal with failure and they postulated an external removal of the inner wall of Schlemm's canal and the external layers of the trabecular meshwork with external trabeculectomy . Iordanidou et al (6) have shown how the bio mechanics of the cornea changes after deep sclerectomy and this may be responsible for success in stabilising field defects independent of the intra ocular pressure . Dua's layer has been shown by Dua et al to affect the corneal biomechanics.It now seems that the removal of the Dua's layer may be central to success of deep sclerectomy due to various reasons, one being imperviousness of this layer ( which gets confused with Descemet's layer) and the other being the fact that the biomechanics of the cornea changes with removal of this layer. We have been doing modified deep sclerectomy since 5 years at our hospitals and go a little ahead anteriorly into the cornea and create a Descemet's window without perforating that window and sometimes we do not see egress of fluid at the removal of deep scleral flap and deroofing of the schlemm's canal and the Descemet's window. We routinely do a video audit of our cases. In our video audit we have noted that in cases where there is no fluid egress the "descemet's membrane" withstands pressure and the air bubble in the anterior chamber is visible and even on increasing the anterior chamber pressure with a large bubble the "descemets membrane" does not rupture. Dua et al (7)have discussed the properties of this layer and it is said to be impervious to air and known to withstand pressures upto 200kPa.We postulate that this is a combination of descemet's layer and Dua's layer which has not been removed. These are the cases in which the deep sclerectomy fails and needs a gonio puncture. In other cases the "descemet's membrane" is very thin and shows egress of fluid spontaneously and sometimes ruptures if the anterior chamber pressure is high due to large air bubble, releasing a small air bubble but no prolapse of iris or sometimes leading to iris prolapse without the membrane being touched. In these cases there is good egress of fluid even from the area of schlemm's canal.These cases of deep sclerectomy are successful. These are the cases where the Dua's layer has been removed and hence the layer remaining in the eye is purely Descemet's layer and allows egress of fluid and cannot withstand pressure. We postulate that the thick membrane that withstands pressure and does not allow egress of fluid easily is a sclerosed peripheral part of Dua's layer which if not removed causes failure of deep sclerectomy necessitating a gonio puncture later. Removing this layer is probably the key to success of Deep Sclerectomy. Further evaluation is needed to substantiate this hypothesis though our video audit shows that, cases in which the layer has not been removed ,fail and need a gonio puncture and the cases in which the Dua's layer is removed are successful and do not need a gonio puncture suggesting that removal of Dua's Layer is essential for success of Deep Sclerectomy, modified or otherwise.

    References:-

    1)Harminder S Dua, Lana A Faraj,Matthew J Branch,Aaron M Yeung,Mohamed S Elalfy,Dalia G Said,Trevor Gray,and James Lowe.The collagen matrix of the human trabecular meshwork is an extension of the novel pre-Descemet's layer (Dua's layer)Br J Ophthalmol 2014 98:691-697;

    2)El Sayyad F(1), Helal M, El-Kholify H, Khalil M, El-Maghraby A.Nonpenetrating deep sclerectomy versus trabeculectomy in bilateral primary open-angle glaucoma.Ophthalmology. 2000 Sep;107(9):1671-4.

    3)Zsolt Varga and Tarek Shaarawy.Deep Sclerectomy: Safety and Efficacy.Middle East Afr J Ophthalmol. 2009 Jul-Sep; 16(3): 123-126.

    4)Guedes RA(1), Guedes VM, Chaoubah A. Factors associated with non-penetrating deep sclerectomy failure in controlling intraocular pressure.Acta Ophthalmol. 2011 Feb;89(1):58-61.

    5)George Kitsos,Miltiades Aspiotis, Yannis Alamanos, Konstantinos Psilas. A modified deep sclerectomy with or without external trabeculectomy: a comparative studyClinical Ophthalmology 2010:4 557-564

    6)Iordanidou V(1), Hamard P, Gendron G, Labb? A, Raphael M, Baudouin C.Modifications in corneal biomechanics and intraocular pressure after deep sclerectomy.J Glaucoma. 2010 Apr-May;19(4):252-6.

    7)Dua HS, Faraj LA, Said DG, Gray T, Lowe J (September 2013). "Human corneal anatomy redefined: a novel pre-Descemet's layer (Dua's layer)". Ophthalmology 120 (9): 1778-85

    Conflict of Interest:

    None declared

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  5. Reply to Response: Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open angle glaucoma

    We thank Huisingh and McGwin (1) for their interest and comments regarding our manuscript describing the optical coherence tomography (OCT) findings after CyPass Micro-Stent implantation for the treatment of open angle glaucoma (2). The importance of formal statistical analysis was considered at the time of submission. Given the small sample size of the study, and the descriptive nature of the study, we found that statistical analysis of this data beyond what is presented in manuscript was not appropriate. We hope future studies with a larger scale and a prospective nature will incorporate more advanced statistical analysis. Based on the findings of our study, we believe that OCT of the supraciliary space can be a powerful predictor of outcomes in patients undergoing CyPass Micro-Stent implantation. Hady Saheb1, Tsontcho Ianchulev2, Iqbal 'Ike' K. Ahmed3 1McGill University, Montreal, QC, Canada; 2University of California San Francisco, San Francisco, CA, USA; 3University of Toronto, Toronto, ON, Canada

    Corresponding author Iqbal 'Ike' K. Ahmed Credit Valley EyeCare 3200 Erin Mills Parkway, Unit 1 Mississauga, Ontario L5L 1W8, Canada Contributors: HS, TI and IKA contributed to the conception of the letter and final approval of the version to be published. REFERENCE 1. Huisingh, C. & McGwin, G. Response: Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open angle glaucoma. Br J Ophthalmol (2014). doi:10.1136/bjophthalmol- 2013-304806 2. SAHEB, H., Ianchulev, T. & Ahmed, I. I. K. Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open-angle glaucoma. Br J Ophthalmol 98, 19-23 (2014).

    Conflict of Interest:

    IIK Ahmed (Transcend Medical: research grant, consultant), H Saheb (Transcend Medical: travel grant), T Ianchulev (Transcend Medical: employee)

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  6. CHARACTERIZATION OF UVEITIS IN ASSOCIATION WITH MULTIPLE SCLEROSIS

    Dear Editor, We congratulate Messenger et al. for their study entitled 'Characterization of uveitis in association with multiple sclerosis'.[1] The authors investigated clinical and demographic characteristics of multiple sclerosis (MS) patients with uveitis. The study has significant results including the ratios of anterior, intermediate and posterior uveitis in this group of MS patients.

    We found out that 54% of MS patients without any visual symptoms and signs had significantly delayed P100 latency in pattern visual evoked potential s (PVEP).[2] This high ratio may mean that clinical symptoms and signs resemble an iceberg in MS world. This finding should force the researchers to use ocular electrophysiologic findings especially in researches including ocular involvement. Therefore, I want to ask to the authors whether they have PVEP results of the patients, but not only the patients included in the study. In case they have, would they mind to investigate the relation between P100 latency and the presence/absence of uveitis in the patients. The authors have a significant number of MS patients. They have the data whether each patient has uveitis. If they have PVEP results too, this gives them an invaluable chance. This is important, because if patients with higher P100 latency have a higher risk of uveitis, then these patients may be suggested to have ophthalmic examinations more frequently than patients with normal P100 latency. That kind of investigation would also add significant contribution to the MS literature.

    REFERENCES 1. Messenger W, Hildebrandt L, Mackensen F, Suhler E, Becker M, Rosenbaum JT. Characterisation of uveitis in association with multiple sclerosis. Br J Ophthalmol 2014 doi: 10.1136/bjophthalmol-2014-305518[published Online First: Epub Date]|. 2. Gundogan FC, Demirkaya S, Sobaci G. Is optical coherence tomography really a new biomarker candidate in multiple sclerosis? - A structural and functional evaluation. Investigative Ophthalmology & Visual Science 2007;48(12):5773-81 doi: Doi 10.1167/Iovs.07-0834[published Online First: Epub Date]|.

    Conflict of Interest:

    None declared

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  7. Three-year follow-up of posterior chamber toric phakic intraocular lens implantation for the correction of high myopic astigmatism in eyes with keratoconus.

    Dear Editor,

    We read with great interest the article by Kamiya et al about use of toric implantable collamer lenses (ICL) in patients with keratoconus. [1] The results are very encouraging. However, we found some discrepancies in the study.

    The mean manifest spherical equivalent was -9.70 D, up to -13.75 D. The Amsler-Krumeich classification system stage 2 includes patients up to -8.0 D of myopia, astigmatism or both.[2] There seems to be a mismatch between the included subjects and inclusion criteria.

    A control arm of patients using only contact lenses could have been taken. Higher order aberrations and contrast sensitivity should have been studied. For assessment of time course of events, the data should have been tested if it is parametric. otherwise Friedman's one-way analysis of variance (ANOVA) test should have been used. Pre operative best corrected visual acuity (BCVA) and post operative uncorrected visual acuity (UCVA) may be compared by Wilcoxon-signed-rank test for evaluation of the intervention on visual acuity.

    Irregular astigmatism at the corneal plane will not be corrected by the toric ICL and can lead to poor post operative vision and should be informed to the patient. This can be evaluated by looking at the rigid contact lens BCVA, and if it is significantly higher than the spectacle corrected BCVA, then after toric ICL implantation, vision will be poor.

    The authors also need to evaluate the centration of cone.[3] A decentred cone will lead to a mismatch between the visual axis, pupillary axis and axis through the cone and distortion of vision. In such cases, reshaping the cone by prior intrastromal ring segments would be useful. The use of the new V4b model of toric ICL with the central hole can also cause aberrations and poor visual quality and its effects need to be studied in eyes with keratoconus.[4]

    References

    1 Kamiya K, Shimizu K, Kobashi H, et al. Three-year follow-up of posterior chamber toric phakic intraocular lens implantation for the correction of high myopic astigmatism in eyes with keratoconus. Br J Ophthalmol Published Online First: 21 August 2014. doi:10.1136/bjophthalmol-2014-305612 2 Choi JA, Kim M-S. Progression of keratoconus by longitudinal assessment with corneal topography. Invest Ophthalmol Vis Sci 2012;53:927-35. doi:10.1167/iovs.11-8118 3 Kummelil MK, Hemamalini MS, Bhagali R, et al. Toric implantable collamer lens for keratoconus. Indian J Ophthalmol 2013;61:456-60. doi:10.4103/0301-4738.116064 4 Huseynova T, Ozaki S, Ishizuka T, et al. Comparative study of 2 types of implantable collamer lenses, 1 with and 1 without a central artificial hole. Am J Ophthalmol 2014;157:1136-43. doi:10.1016/j.ajo.2014.01.032

    Conflict of Interest:

    None declared

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  8. Re:Reproducibility of aberrometry-based intraoperative refraction during cataract surgery, Statistical issues

    Dear Sirs, We are grateful to Sabour and Ghassemi for their interest in our recent article[1]. In our understanding, they query why we did not use intra class correlation (ICC) as a measure for precision. Our test-retest reliability (absolute agreement ICC) is derived from the maximum likelihood (LM) estimates of the one-way random effects model of the form: yij=Mu+ri+Epsilonij, where yij is the measurement of the ith eye by the jth measurement (say spherical equivalent measured on the first (second or third) occasion), Mu is the mean rating (say mean spherical equivalent), ri is the eye random effect and Epsilonij is a random error. As described in Rabe-Hesketh and Skrondal[2], the reliability is calculated as p ?=? ?/(? ?+? ?), where Psi is a between-subject variance and Theta is a within-subject variance. Here we assume that n eyes are randomly selected from the population of potential eyes. Each one is measured by a different set of k measurements, randomly drawn from the population of potential measurements. The consistency of agreement is not defined in this case, as each eye is evaluated by a different set of measurements. Thus, there is no between- measurements variability in this model. We agree that clinical judgement is paramount, which is why, indeed, we state in our paper (p 5) that "the clinical interpretation of the agreement range (...) is vital (underlining added)". It is before the background of such clinical interpretations in the paper and of the above explanations that we derived our conclusions in, as we trust, an appropriate way. Yours respectfully,

    References

    1. Huelle JO, Katz T, Druchkiv V, et al. First clinicial results on the feasibility, quality and reproducibility of aberrometry-based intraoperative refraction during cataract surgery. Br J Ophthalmol 2014. 2. Rabe-Hesketh S, Skrondal A. Multilevel and Longitudinal Modeling Using Stata, Second Edition: Stata Press, 2008. 3. McAlinden C, Khadka J, Pesudovs K. Statistical methods for conducting agreement (comparison of clinical tests) and precision (repeatability or reproducibility) studies in optometry and ophthalmology. Ophthalmic Physiol Opt 2011;31(4):330-8.

    Conflict of Interest:

    None declared

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  9. An additional explanation for azithromycin's efficacy in treating meibomian gland dysfunction

    We would like to congratulate Dr. Kashkouli et al for their recently published paper "Oral azithromycin versus doxycycline in meibomian gland dysfunction: a randomized double masked open label clinical trial". The authors found that azithromycin induced a significantly better overall clinical response than doxycycline, and attributed this effect to the antibacterial and anti-inflammatory effects of azithromycin. However, we would like to suggest an additional explanation for their results. We have discovered that azithromycin can directly increase lipid accumulation and promote terminal differentiation of human meibomian gland epithelial cells in vitro.1 This effect may be due to azithromycin's cationic amphiphilic structure and an associated phospholipidosis.2 We have also discovered that the stimulatory action of azithromycin on human meibomian gland epithelial cells is unique, and cannot be duplicated by exposure to doxycycline, minocycline or tetracycline.2 3 In effect, this lipid- promoting activity of azithromycin may improve the quality of meibomian gland secretions, alleviate the evaporative dry eye, and attenuate such additional signs as conjunctival redness and ocular surface staining. Overall, this ability of azithromycin to promote human meibomian gland epithelial cell function may account for its greater efficacy, as compared to doxycycline, in alleviating the signs and symptoms of human meibomian gland dysfunction.

    References

    1. Liu Y, Kam WR, Ding J, et al. Effect of azithromycin on lipid accumulation in immortalized human meibomian gland epithelial cells. JAMA ophthalmol 2014;132(2):226-8. 2. Liu Y, Kam WR, Ding J, et al. One man's poison is another man's meat: using azithromycin-induced phospholipidosis to promote ocular surface health. Toxicology 2014;320:1-5. 3. Liu Y, Kam WR, Ding J, et al. The effect of macrolide and tetracycline antibiotics on lipid expression in human meibomian gland epithelial cells. ARVO abstract 2014.

    Conflict of Interest:

    A provisional patent has been filed around the technology mentioned in our paper. The intellectual property for the application is owned by the Schepens Eye Research Institute/Massachusetts Eye and Ear.

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  10. Reporting of harms in clinical trials: why do we continue to fail?

    O'Day and colleagues describe in their recent paper the inadequate reporting of harm in randomized controlled trials of intra-vitreal therapies for diabetic macular oedema(O'Day et al., 2014). At first glance, the results are alarming. An average of only six recommendations of the 2004 CONSORT guidelines extension covering harms were met. Ophthalmologists are not alone in their inadequate reporting, however. Several other studies have found similar, and often worse examples of heterogenous and selective reporting of harm in RCTs in psychological medicine(Jonsson et al., 2014), asthma(Ntala et al., 2013) and cancer(Sivendran et al., 2014). Why, then, are we falling so far short of these internationally agreed standards, and who is to blame?

    Some might argue that there are too many recommendations. The CONSORT guidelines have 25 points, of which one is harm reporting (with ten recommendations)(Schulz et al., 2010). Whilst most published RCTs do not report them all, many do report on half or more (interquartile range 5-7 for the ophthalmic studies cited)(O'Day et al., 2014). In any case, they remain "recommendations", not "requirements" In order to address this, the recommendations might be adapted to suggest full reporting be made publically available elsewhere to limit the length of published reports.

    Perhaps the authors of the RCTs published are to blame? Could it be that they simply do not the data needed to fulfill the ten requirements? Whilst it is possible, and in some cases may highlight the need for investment in training, most authors could likely fulfill more of the ten recommendations than they currently do, for example the number of patients withdrawn due to an adverse event (only 36% in ophthalmic trials)(O'Day et al., 2014), essential data that most investigators surely can trace(Ioannidis JA and Lau J, 2001).

    Finally, it might be argued that journal editors are to blame for failing to implement these standards. This may not be an option for all except editors of the minority of most desirable publications. Raising the bar too high may lead to authors taking their work elsewhere where they know it will be accepted.

    How, then, to move forward? Like many "culture change" challenges faced in modern medicine, the adequate adoption of such standards requires a concerted effort by all parties involved in the research-publication pathway. John Kotter's 8-step change model provides some insights as to how, including establishing a sense of urgency by highlighting the harms associated with poor reporting, and forming powerful coalitions(Kotter, 1996). Most importantly, however, we as researchers must champion the improvement of reporting standards in our own work and demand this of our peers. Only then can we hope for change.

    Ioannidis JA, and Lau J (2001). Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas. JAMA 285, 437-443. Jonsson, U., Alaie, I., Parling, T., and Arnberg, F.K. (2014). Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: a review of current practice. Contemp. Clin. Trials 38, 1-8. Kotter, J.P. (1996). Leading Change (Harvard Business Press). Ntala, C., Birmpili, P., Worth, A., Anderson, N.H., and Sheikh, A. (2013). The quality of reporting of randomised controlled trials in asthma: a systematic review. Prim. Care Respir. J. J. Gen. Pract. Airw. Group 22, 417-424. O'Day, R., Walton, R., Blennerhassett, R., Gillies, M.C., and Barthelmes, D. (2014). Reporting of harms by randomised controlled trials in ophthalmology. Br. J. Ophthalmol. 98, 1003-1008. Schulz, K.F., Altman, D.G., and Moher, D. (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann. Intern. Med. 152, 726-732. Sivendran, S., Latif, A., McBride, R.B., Stensland, K.D., Wisnivesky, J., Haines, L., Oh, W.K., and Galsky, M.D. (2014). Adverse event reporting in cancer clinical trial publications. J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 32, 83-89.

    Conflict of Interest:

    None declared

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