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...
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.
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...
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
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...
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?
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...
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.
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 statist...
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)
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.
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]|.
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, as...
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
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...
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.
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 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.
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 oth...
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).
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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...
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...
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...
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...
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 statist...
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%...
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, as...
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...
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,...
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 oth...
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