Cataract remains the largest single cause of avoidable blindness worldwide. In 2020 an estimated 43.3 million people were blind, and cataract accounted for 15.2 million of those cases among adults aged 50 years and older — more than glaucoma, uncorrected refractive error and age-related macular degeneration combined.1,2 Although the age-standardised prevalence of avoidable blindness has fallen over three decades, population growth and ageing have increased the absolute number of affected people, so the volume of cataract surgery required continues to rise.2 Two techniques dominate contemporary practice. Phacoemulsification, described by Kelman in 1967, fragments the nucleus with ultrasonic energy and permits its removal through a small incision.3 Manual small-incision cataract surgery (MSICS) delivers the nucleus through a self-sealing scleral tunnel without ultrasound.4 MSICS is quicker, requires no phacoemulsification console and costs the provider considerably less: in a large south Indian programme the direct provider cost was 25.55 US dollars for phacoemulsification against 17.03 US dollars for MSICS.5,6 These properties have made MSICS the mainstay of high-volume cataract services across South Asia and sub-Saharan Africa.5 Whichever technique is used, the corneal endothelium bears the cost. The adult human corneal endothelium is effectively post-mitotic; cellularity declines by roughly 0.56% each year through life, and in vivo confocal work reports a comparable 0.5% annual reduction in endothelial cell density.7,8 Cells lost to surgical trauma are not replaced but compensated for by enlargement and migration of survivors, so every operation permanently consumes functional reserve. When density falls below the threshold needed to maintain stromal deturgescence, the cornea decompensates. Nuclear hardness, infusion volume and intraocular lens type are established independent predictors of endothelial loss during phacoemulsification.9 Whether MSICS or phacoemulsification is gentler on the endothelium has been examined repeatedly with inconsistent results. A randomised trial of 200 eyes found no difference in six-week endothelial cell loss (P = 0.44 by manual counting),10 and successive syntheses have reached the same conclusion (P = 0.45 across six randomised trials; P = 0.298 across 11 comparative studies of 76 838 eyes).11,12,13 Against this, single-centre series have reported significant between-group differences at one and six weeks,14 and a comparative study restricted to white cataract found lower loss after MSICS at three months (11.8% vs 15.8%), although that difference did not reach significance.15 Interpretation is complicated by a confounder that is rarely acknowledged. Most comparisons implant a foldable lens after phacoemulsification and a rigid lens after MSICS, so the reported contrast conflates ultrasound exposure with incision size. In many Indian teaching hospitals cost constrains both arms to a rigid polymethyl methacrylate lens, which requires a sclerocorneal incision of about 5.5 mm irrespective of how the nucleus was removed. That configuration removes the incision-size advantage of phacoemulsification and isolates the endothelial cost of ultrasonic energy, yet studies reporting it with follow-up beyond six weeks are scarce.16 We therefore compared endothelial cell density over six months after MSICS and after phacoemulsification, both ending with rigid lens implantation through a sclerocorneal incision at the steeper meridian, hypothesising that endothelial loss at six months would not differ between the two techniques

Study design and setting This prospective, comparative, hospital-based interventional study was conducted in the Department of Ophthalmology, Ballari Medical College and Research Centre, Ballari, Karnataka, India, between August 2022 and January 2024. Reporting follows the STROBE recommendations for observational research.17 The protocol was approved by the Institutional Ethics Committee ([INSERT full committee name, approval reference number and date of approval]) and the study adhered to the Declaration of Helsinki. Written informed consent was obtained from every participant before enrolment. Participants Consecutive patients aged 40 years or older attending the outpatient department with visually significant age-related cataract and nuclear sclerosis of grade 3 or below on the Lens Opacities Classification System III (LOCS III)18 were assessed for eligibility. Patients were excluded for corneal opacity, any primary endothelial disorder, ocular disease other than cataract, traumatic or complicated cataract, previous refractive surgery, monocular status, or declining participation. Eyes sustaining an intraoperative complication such as vitreous loss were excluded from analysis. One eye per patient was studied. Allocation and masking Patients were enrolled by consecutive sampling and assigned to MSICS (Group A) or phacoemulsification (Group B), 30 to each arm. [INSERT the exact basis on which each patient was assigned to a technique — alternate allocation, surgeon judgement, patient choice or theatre list. This is the first item reviewers will query, and the source records describe the process inconsistently as both consecutive and random.] Neither participants nor the operating surgeon were masked to the allocated technique. Sample size Sample size was calculated for the difference in mean postoperative endothelial cell density between two independent groups, assuming group means of 2247.80 and 2018.80 cells/mm² with standard deviations of 353.8 and 290.45 respectively (pooled standard deviation 323.679), α = 0.05 and 80% power (Z1 = 1.64485, Z2 = 0.84162). The requirement was 25 eyes per group (24.70 rounded up), and 30 were recruited per group to allow for attrition. [INSERT the published source of the assumed means and standard deviations.] The value used for Z1 corresponds to a one-sided α; a two-sided formulation would have required a larger sample, and this is acknowledged as a limitation. Preoperative assessment Every patient underwent history taking, Snellen visual acuity testing and refraction, slit-lamp biomicroscopy, intraocular pressure measurement, lacrimal syringing, keratometry (Bausch and Lomb), A-scan biometry with intraocular lens power calculated by the SRK II formula, and gonioscopy or B-scan ultrasonography where indicated. Cataract was graded at the slit lamp against LOCS III standards, whose 95% tolerance limits are 0.7 for nuclear opalescence and nuclear colour, 0.5 for cortical and 1.0 for posterior subcapsular opacity.18 Specular microscopy Central corneal endothelial cell density was measured by non-contact specular microscopy ([INSERT manufacturer, model, software version and country]) preoperatively and on postoperative day 1, at 1 week and at 6 monthsThe same instrument and the same operator were used throughout the study. Surgical technique All operations were performed by a single experienced surgeon. In Group A a scleral tunnel was fashioned at the steeper meridian, followed by capsulotomy, hydroprocedures, nucleus delivery, cortical aspiration and implantation of a rigid polymethyl methacrylate posterior chamber intraocular lens. In Group B a sclerocorneal incision of 5.5 mm was made at the steeper meridian, the nucleus was emulsified with ultrasonic energy, and the same rigid polymethyl methacrylate lens was implanted. Postoperative treatment was identical in the two groups. Outcomes The primary outcome was the change in central endothelial cell density from baseline to 6 months. Secondary outcomes were endothelial cell density on day 1 and at 1 week, the between-group difference at each time point, and percentage endothelial cell loss from baseline. Statistical analysis Data were entered in Microsoft Excel and analysed in IBM SPSS Statistics version 26 (IBM Corp., Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation and categorical variables as counts with percentages. Between-group comparisons used the independent-samples t test for continuous variables and the chi-square or Fisher exact test for categorical variables. Within-group change from baseline was assessed by the paired t test with 95% confidence intervals for the mean difference. Percentage endothelial cell loss was calculated from the group means as (preoperative density minus postoperative density) divided by preoperative density, multiplied by 100. A two-sided P value below 0.05 was taken as significant. No imputation was required, as there were no missing observations.

Participants Sixty eyes of 60 patients completed all four assessments, 30 in each group, with no loss to follow-up. Mean age was 60.50 ± 10.32 years overall, 60.80 ± 9.45 years in Group A and 60.20 ± 10.87 years in Group B (t = 0.228, P = 0.820); ages ranged from 41 to 80 years, and 26 patients (43.3%) were aged 51 to 60 years. Group A comprised 14 men (46.7%) and 16 women (53.3%) and Group B 17 men (56.7%) and 13 women (43.3%) (χ² = 0.601, P = 0.438). Cataract morphology was similarly distributed (Fisher exact P = 0.849); the commonest pattern in both arms was nuclear sclerosis grade 2 with posterior subcapsular opacity, in 11 eyes (36.6%) of each group. Baseline characteristics appear in Table 1. No intraoperative complication occurred in either group, and no eye was excluded after surgery. Endothelial cell density: between groups Preoperative endothelial cell density was 2555.23 ± 200.58 cells/mm² in Group A and 2536.03 ± 310.87 cells/mm² in Group B, a difference of 19.20 cells/mm² (2555.23 − 2536.03) that was not significant (t = 0.284, P = 0.777). On postoperative day 1 density was 2505.14 ± 216.44 cells/mm² after MSICS and 2282.76 ± 409.83 cells/mm² after phacoemulsification; the difference of 222.38 cells/mm² (2505.14 − 2282.76) favoured MSICS and was significant (t = 2.473, P = 0.017). By 1 week the groups no longer differed (2523.92 ± 217.21 vs 2419.30 ± 390.14 cells/mm²; difference 104.62 cells/mm² (2523.92 − 2419.30); t = 1.284, P = 0.204), and at 6 months the difference was 87.64 cells/mm² (2512.70 − 2425.06; t = 1.209, P = 0.232). Table 2 present these comparisons. Endothelial cell density: within groups In Group A, density fell from baseline to 2505.14 ± 216.44 cells/mm² on day 1, a mean reduction of 50.23 cells/mm² (95% CI 14.31 to 98.57; t = 2.754, P = 0.015). The reduction from baseline was not significant at 1 week (31.31 cells/mm²; 95% CI −1.59 to 64.13; t = 1.823, P = 0.086) or at 6 months (42.53 cells/mm²; 95% CI −2.74 to 87.81; t = 1.862, P = 0.081). In Group B the day-1 reduction was 253.27 cells/mm² (95% CI 102.71 to 364.9; t = 3.681, P = 0.001) and the 1-week reduction 116.73 cells/mm² (95% CI 11.06 to 222.4; t = 2.210, P = 0.038); by 6 months the reduction was not significant (t = 1.904, P = 0.064). Paired comparisons are set out in Table 3. Percentage endothelial cell loss Calculated from the group means, endothelial cell loss from baseline in Group A was 1.96% on day 1 (50.09 ÷ 2555.23 × 100), 1.23% at 1 week and 1.66% at 6 months. In Group B it was 9.99% on day 1 (253.27 ÷ 2536.03 × 100), 4.60% at 1 week and 4.38% at 6 months (Table 4). In both groups the measured density was higher at 1 week and at 6 months than it had been on day 1.

Six months after surgery, corneal endothelial cell density did not differ significantly between eyes that underwent MSICS and eyes that underwent phacoemulsification, and in neither arm was the reduction from baseline statistically significant at that point. The only significant between-group difference arose on the first postoperative day, when density measured after phacoemulsification was 222.38 cells/mm² lower than after MSICS. That day-1 divergence, and its subsequent disappearance, deserve careful reading rather than celebration. The adult corneal endothelium does not proliferate,7,8 so the apparent rise in measured density between day 1 and 1 week in both arms cannot represent recovery of lost cells. Two explanations are plausible and not mutually exclusive. First, specular microscopy performed through an oedematous cornea on the first postoperative day yields degraded images, and automated cell-border tracing systematically misreads them; the day-1 value is therefore the least reliable measurement in the series and should be interpreted as an index of corneal oedema rather than of cell death. Postoperative corneal swelling on day 1 correlates strongly with endothelial cell loss measured at three months (R² = 0.785),20 which supports treating the early reading as a marker rather than a measurement. Second, surviving endothelial cells enlarge and migrate to re-cover a denuded area over days to weeks, so the counting field sampled at 1 week is not the same population as that sampled on day 1. The practical implication is that the six-month value, not the day-1 value, is the defensible estimate of permanent endothelial cost, and on that measure the two techniques were equivalent. Our six-month finding is concordant with the larger randomised and pooled evidence. Gogate and colleagues randomised 200 eyes and found six-week endothelial loss of 543.4 cells/mm² after phacoemulsification and 505.9 cells/mm² after MSICS by manual counting (P = 0.44), with corrected distance visual acuity better than 6/18 in 98.5% and 97.3% of eyes respectively.10 A meta-analysis of six randomised trials comprising 1315 eyes found no difference in percentage endothelial cell count loss (P = 0.45),12 and a broader synthesis of 11 comparative studies reached the same conclusion (P = 0.298).13 The Cochrane review of eight trials in 1708 participants found equivalent best-corrected visual acuity of 6/18 or better (pooled risk ratio 0.99, 95% CI 0.98 to 1.01), with uncorrected acuity modestly favouring phacoemulsification (0.90, 95% CI 0.84 to 0.96).11 Where discordant results have been reported they cluster in the early postoperative window: Ganekal and Nagarajappa found a significant between-group difference in endothelial cell density at one and six weeks in 200 eyes (P = 0.016) yet concluded that endothelial function and morphology were preserved in both arms,14 and Kongsap, studying white cataract, found lower loss after MSICS at three months (11.8% vs 15.8%) that did not reach significance (P = 0.111).15 Ammous and colleagues, with a minimum follow-up of six months, similarly reported that the greatest cell loss occurred in the immediate postoperative period in both arms.16 The pattern across this literature is consistent: differences that look real at day 1 to week 6 attenuate with time. The absolute losses we observed — 1.66% after MSICS and 4.38% after phacoemulsification at six months — are appreciably lower than most published series, which report figures between 4% and 16% and, in dense nuclei, as high as 35% to 39%.25,27 Three features of our cohort plausibly account for this. Eligibility was restricted to nuclear sclerosis of LOCS III grade 3 or below, and nuclear hardness is the single strongest independent predictor of endothelial injury during phacoemulsification.9 All surgery was performed by one experienced surgeon, removing the surgeon-related variance that inflates loss in multi-surgeon and teaching series. Eyes with intraoperative complications, uveitic or diabetic disease were excluded, and both of the latter substantially increase endothelial vulnerability: three-month loss after MSICS reaches 27.5% in patients with diabetes against 18.3% in matched controls,23 and diabetic corneas show a slower endothelial healing response despite comparable phaco energy.24 A fourth possibility deserves stating plainly — automated specular counts can drift upward when image quality is imperfect, so uncorrected automated analysis may understate true loss in any of these series, including ours. Mechanistically, the near-equivalence at six months is what the surgical configuration predicts. Both arms received a rigid polymethyl methacrylate lens through a sclerocorneal incision of similar size at the steeper meridian, so the incision-related component of endothelial trauma was matched by design and the residual contrast was ultrasound exposure alone. In modern phacoemulsification that exposure is modest when nuclei are soft and fluidics are conservative: low aspiration parameters produce smaller corneal thickness changes without altering three-month endothelial cell density (P = 0.45),28 microcoaxial surgery through a 2.3 mm incision yields a mean density loss of only 5.8%,29 and the temperature of the irrigating solution has no detectable endothelial effect.30 The choice of ophthalmic viscosurgical device may matter more than the technique label: dispersive agents coat 87% of the endothelial surface against 71% for cohesive agents, rising to 93% with the soft-shell technique,31 and endothelial loss during MSICS itself differs markedly according to whether nucleus delivery is viscoelastic-assisted or performed under continuous irrigation (day-30 loss 9.7% vs 4.8%).21,22 Technique-level comparisons that ignore these variables risk attributing to the incision what belongs to the viscoelastic. These findings have direct service implications. Cataract volume in India and comparable settings is constrained by cost and by equipment availability rather than by evidence of superiority.5 If endothelial safety at six months is equivalent, the case for MSICS in high-volume and resource-limited environments rests on its lower provider cost,6 shorter operating time — 11.2 ± 2.4 minutes against 14.2 ± 3.1 minutes for phacoemulsification in one randomised comparison33 — and its independence from a console. MSICS also retains a role in eyes where phacoemulsification is hazardous, including uveitic cataract, where the two techniques do not differ in endothelial loss or complication rates.32 At the other end of the technology spectrum, femtosecond laser assistance reduces six-month endothelial loss in dense cataract relative to conventional phacoemulsification (12.8% vs 16.08%),25 yet the Cochrane synthesis of 42 randomised trials in 7298 eyes found no important difference in endothelial cell loss overall (mean difference 12 cells/mm², 95% CI −40 to 64) and suggested the laser is the less cost-effective option.26 Across a fourfold range of capital cost, the endothelial outcome is largely unchanged. Strengths The study was prospective, with complete six-month follow-up in all 60 eyes and no attrition. All surgery was performed by one experienced surgeon using a standardised protocol, and the two arms were matched by design for intraocular lens material and incision configuration — a source of confounding that most published comparisons leave uncontrolled. Groups were well balanced at baseline for age, sex, cataract morphology and endothelial cell density, and follow-up extended to six months, beyond the six-week horizon of most comparative studies. Limitations Several limitations qualify these findings. Allocation was not randomised, and the source records describe the assignment process inconsistently, so selection bias cannot be excluded; the surgeon may have preferred one technique for particular eyes. Neither participants, surgeon nor the specular microscopy observer were masked. The sample of 30 eyes per arm was calculated to detect a difference in absolute postoperative density of roughly 229 cells/mm² using a one-sided α, so the study is underpowered for the smaller between-group differences actually observed at 1 week and 6 months, and the non-significant results should be read as inconclusive rather than as evidence of equivalence. Endothelial morphology — coefficient of variation and percentage hexagonality — was not reported, although these are more sensitive indicators of endothelial stress than density alone. Ultrasound time and cumulative dissipated energy were not recorded, which prevents any dose-response analysis. Findings apply only to nuclei of LOCS III grade 3 or below and cannot be extended to dense or white cataract, where the techniques diverge most. Finally, the study was conducted at a single centre by a single surgeon, which strengthens internal consistency at the expense of generalisability. Clinical implications For units choosing between techniques on endothelial grounds alone, these data offer no reason to prefer phacoemulsification for cataract of LOCS III grade 3 or below when a rigid lens is to be implanted. The first postoperative day should not be used to judge endothelial outcome; a measurement at six weeks or later is required before counselling a patient about endothelial reserve. Where preoperative density is marginal, technique choice is likely to matter less than nuclear grade, viscoelastic selection and conservative fluidics. Future research Adequately powered randomised comparisons are needed that report endothelial morphology alongside density, record cumulative dissipated energy so that endothelial cost can be related to ultrasound dose, follow patients for at least twelve months, and stratify by nuclear grade. Trials in dense and white cataract, where the two techniques are most likely to differ, would be more informative than further studies in soft nuclei. Standardising the viscoelastic and the intraocular lens across arms, as was done here, should become the default design

In eyes with cataract of LOCS III grade 3 or below receiving a rigid polymethyl methacrylate intraocular lens through a sclerocorneal incision, endothelial cell density at six months did not differ significantly between manual small-incision cataract surgery and phacoemulsification. Phacoemulsification produced a significantly lower measured density on the first postoperative day, but that difference resolved and is better understood as a reflection of early corneal oedema than of permanent cell loss. MSICS remains an endothelially safe option where phacoemulsification is unavailable or unaffordable

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Nepal J Ophthalmol. 2015;7(14):124-34. doi:10.3126/nepjoph.v7i2.14962. PMID: 27363957. 33. Bhargava R, Kumar P, Sharma SK, Arora Y. Phacoemulsification versus manual small incision cataract surgery in patients with Fuchs heterochromic iridocyclitis. Asia Pac J Ophthalmol (Phila). 2016;5(5):330-4. doi:10.1097/APO.0000000000000191. PMID: 26939115.