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Ijo 70 3967

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November 2022 Morya, et al.

: Corneal endothelial cell loss during manual small-incision cataract surgery 3967

Commentary: Comparison of corneal There was no difference in the two groups with respect
to vision, intraocular pressure, and horizontal and vertical
endothelial cell loss during manual keratometry readings after surgery. Randomization ensured
small-incision cataract surgery that the groups were similar at baseline. There was a statistically
significant difference in the central corneal thickness; however,
using viscoelastic‑assisted nucleus it was not clinically significant as postoperative visual acuity on
removal versus continuous basal salt day 30 and intraocular pressure were similar in both groups.
There was obviously a significant difference in vision before
solution plus technique - Randomized and after surgery!
controlled trial The difference in the endothelial cell count was statistically
significant, group 1 and group 2 had a 9% and 4.6% reduction
There have been a few randomized control trials comparing on day 1, and 9.7% and 4.8% on day 30, respectively. Thus
phacoemulsification and manual small-incision cataract visco‑assisted nucleus delivery had a more deleterious effect
surgery (SICS);[1,2] however, there have been none comparing on endothelial cells as compared to a balanced solution.
the different techniques of manual SICS using a rigorous
The takeaway was that endothelial cell loss was slightly less
scientific method. Morya et al.[3] need to be congratulated for
in the BSS group. Although this was statistically significant, it
bridging this lacuna. Randomized control trials are one of
did not translate into any difference in visual acuity or other
the highest hierarchies of evidence in scientific studies. The
parameters. This small difference would be important in
reporting of RCTs should be as per the CONSORT statement.[4]
This study by Morya et al. fulfils many CONSORT criteria. cataract eyes with Fuchs dystrophy, corneal guttata, or similar
condition with poor endothelial cell counts. One wonders
For the enrolment, the study should detail the eligibility what would have been the result if the more commonly used
criteria and also report those who declined to participate, Ringer’s lactate was used instead of BSS plus as the irrigating
or those who were excluded for other reasons. This study solution?
was done at a tertiary care center where enrolment went
on for 3 years (due to the COVID pandemic?) to recruit Similar results were seen in a randomized control trial
206 participants. The authors do not elucidate how many published in the Indian Journal of Ophthalmology in 2009,
were excluded and the 206 were part of what larger sample in which BSS was compared with Ringer’s lactate to observe
was considered for enrolment. There were 63.2% males, a the endothelial cell loss, central corneal thickness, and
preponderance of one gender; however, they were equally postoperative inflammation after phacoemulsification.[6] The
divided among the two groups. Authors have included hard BSS group had lesser endothelial cell loss and corneal edema;
cataracts but there were a few cataracts with 4+ nuclear however, there was no mention of visual acuity in both arms,
sclerosis. Preoperatively, group 1 had more myopic eyes, which was similar.[6,7]
whereas group 2 had lesser preoperative vision. The authors state that BSS may be used in settings where
CONSORT statement states details of randomization should viscoelastic cannot be procured, as it was in some places
be mentioned and how the masking is done. The randomization during the COVID pandemic. However, supply chains in
in this study was done using computer‑generated binary such situations would have interfered with most surgical
numbers, and the single surgeon was masked until the start consumables. Procuring intraocular lenses and ophthalmic
of the surgery, as were the team members to perform the surgical consumables is a challenge on islands and in some
pre‑ and post‑operative evaluation. The details of allocation to African countries but this is an exception rather than a rule.
intervention and who received what form of treatment have
This special issue highlights numerous techniques of
been reported.
manual SICS, all of which are reported to give excellent visual
The new CONSORT statement also looks at to delay between outcomes. It would be in the interest of our patients and the
randomization and allocation and eligibility criteria for the ophthalmic fraternity if the rigorous method of randomized
eye care center and care providers.[5] It also asks whether control trials were to be applied to each new technique so
important changes were made to interventions versus what that we may understand their benefits and limitations better.
was planned. Both these have not been mentioned in this study. The authors Morya et al. have started this journey of holding
There should also be details of follow‑up, including those lost a candle to various techniques of manual SICS. May their
to follow‑up, and those who discontinued the treatment. The tribe increase.
follow‑up was on day 1, and day 30 after surgery, by which
times most postoperative parameters would be stable. The short
follow‑up was a major limitation but this period was enough
Parikshit Gogate1,2,3
to differentiate changes in the corneal thickness and visual 1
Department of Ophthalmology, D. Y. Patil Medical College, Pune,
acuity. The analysis should ideally have been on intention to Maharashtra, India, 2Community Eye Care Foundation,
treat basis; however, the authors do not report if any patient Dr. Gogate’s Eye Clinic, Pune, Maharashtra, India,
needed a larger incision, or if there was any deviation from
3
School of Health Sciences, Queens University, Belfast,
the protocol. We may assume that nobody was excluded for United Kingdom
a reason. Correspondence to: Dr. Parikshit Gogate,
All participants underwent manual SICS under the Community Eye Care Foundation, Dr. Gogate’s Eye Clinic,
peribulbar block, with a 7 mm scleral tunnel that was not 102‑202, Kumar Garima, TadiwalaRoad, Pune ‑ 411 001,
sutured. The authors were concerned about patient safety Maharashtra, India.
and comfort. E‑mail: parikshitgogate@hotmail.com
3968 Indian Journal of Ophthalmology Volume 70 Issue 11

References postoperative outcomes after phacoemulsification: A randomized


clinical trial. Indian J Ophthalmol2009;57:191‑5.
1. Gogate P, Kulkarni S, Krishnaiah S, Deshpande R, Joshi S, 7. Gogate P, Deshpande M. Is balanced salt solution really superior
Palimkar A, et al. Safety and efficacy of phacoemulsification to ranger lactate for phacoemulsification. Indian J Ophthalmol
compared with manual small incision cataract surgery by a 2010;58:168‑9.
randomized control trial: Six weeks results. Ophthalmology
2005;112:869‑74.
2. Gogate P, Ambardekar P, Kulkarni S, Deshpande R. Joshi S, This is an open access journal, and articles are distributed under the terms of
Deshpande M. Comparison of endothelial cell loss after cataract the Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 License,
surgery: Phacoemulsification versus manual small incision cataract which allows others to remix, tweak, and build upon the work non‑commercially,
surgery: Six weeks results of a randomized controlled trial. as long as appropriate credit is given and the new creations are licensed under
J Cataract Refract Surg 2010;36:247‑53. the identical terms.

3. Morya AK, Gurnani B, Mishra D, Kaur K, Porwal A, Sisodia P,


et al. Comparison of corneal endothelial cell loss during manual Access this article online
small‑incision cataract surgery using viscoelastic‑assisted nucleus Quick Response Code:
Website:
removal versus continuous balanced salt solution plus technique - www.ijo.in
Randomized controlled trial. Indian J Ophthalmol 2022;70:3960-6.
DOI:
4. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT
10.4103/ijo.IJO_2164_22
2010 statement: updated guidelines for reporting parallel group
randomised trials. BMJ 2010;340:c332.
5. Boutron I, Altman DG, Moher D, Schulz KF, Revaud P, CONSORT
NPT Group. CONSORT statement for randomized trials of
non‑pharmacologic treatments: A 2017 update and a CONSORT
extension for non‑pharmacologic trial abstracts. Ann Int Medicine Cite this article as: Gogate P. Commentary: Comparison of corneal
2017;167:40‑7. endothelial cell loss during manual small-incision cataract surgery using
6. Vasavada V, Vasavada V, Dixit NV, Raj SM, Vasavada AR. viscoelastic‑assisted nucleus removal versus continuous basal salt solution plus
technique - Randomized controlled trial. Indian J Ophthalmol 2022;70:3967-8.
Comparison between Ringer’s lactate and balanced salt solution on

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