Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 8, 2026
Open Peer Review Period: Mar 9, 2026 - May 4, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Incidence and Anatomical Distribution of Primary Posterior Capsular Opacity During Cataract Surgery in a Rural Population: Prospective Observational Study Protocol
ABSTRACT
Background:
Primary posterior capsular opacity (PCO) is opacity identified on the posterior capsule immediately after cortical clean-up during cataract surgery, encompasses fibrotic posterior capsule plaque and early lens epithelial cell (LEC)-proliferative changes. In rural populations where advanced cataracts predominate, intraoperative capsular pathology is common yet poorly characterised across cataract morphologies. Existing studies conflate distinct opacity types and rely on unmasked subjective assessment.
Objective:
This study aims to determine the incidence of primary PCO across all cataract morphologies operated on by a single surgeon at a rural tertiary care centre and to describe its anatomical distribution across posterior capsule zones.
Methods:
This is a 2-year, prospective, observational, single-surgeon study at Acharya Vinoba Bhave Rural Hospital (AVBR Hospital), Wardha, India. A total of 142 adults (minimum n = 129; 10% attrition allowance) will be enrolled. Intraoperative PCO will be classified as Type A (plaque) or Type B (LEC-proliferative) using a pre-specified decision tree, graded on a 4-point scale (0–3) by two independent masked observers using retroillumination photographs (operating microscope + slit-lamp). EPCO grading will be applied at postoperative day 1, week 6 (±1 week), month 6 (±2 weeks), and month 12 (±1 month). Primary outcome is PCO incidence (Wilson score 95% CI). Secondary outcomes include anatomical distribution, longitudinal best-corrected visual acuity (BCVA in logMAR) by linear mixed-effects model, and 12-month Nd:YAG capsulotomy rate. Multivariable logistic regression will adjust for surgical technique, IOL type and edge design, cataract morphology, and age. Missing data will be handled by multiple imputation (MICE).
Results:
Ethics approval was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Ref: DMIHER(DU)/IEC/2025/374) on June 30, 2025. The study was prospectively registered with the Clinical Trials Registry of India (CTRI/2025/11/097770) on November 20, 2025. Participant recruitment began in November 2025 at Acharya Vinoba Bhave Rural Hospital, Wardha, India. As of March 2026, recruitment is ongoing. The planned recruitment period is 24 months, with a target sample size of 142 participants. Data collection is expected to conclude by late 2027, and the final study findings are anticipated to be published in 2028.
Conclusions:
This protocol provides a rigorous, objectively graded, morphology-stratified framework for characterising intraoperative capsular pathology in a rural Indian cataract population, with direct implications for surgical planning and Nd:YAG resource allocation. Clinical Trial: Clinical Trials Registry of India (CTRI/2025/11/097770) on November 20, 2025
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