Surgical Outcome of Iris Claw and Scleral Tuck Intraocular Lens in Primary Cataract Surgery by Phacoemulsification in a Tertiary Care Center: Protocol for a Randomized Controlled Trial

Abstract Background Cataract remains the leading cause of reversible blindness worldwide, particularly in older adults, in whom capsular weakness during phacoemulsification may preclude posterior chamber intraocular lens (IOL) implantation. In such scenarios, alternative fixation methods such as scleral-sutured and iris-claw lenses are preferred. However, direct comparative evidence regarding their safety, stability, and postoperative visual outcomes during primary cataract surgery is limited. Objective This study aims to compare the surgical and visual outcomes between retropupillary iris-claw IOL implantation and scleral-sutured fixation of single-piece foldable IOLs performed during primary cataract surgery by phacoemulsification in patients with inadequate capsular support. Methods This is a prospective, 2-arm, open-label randomized controlled trial being conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Sawangi, India. A total of 92 patients aged 35 to 75 years with intraoperative posterior capsular compromise will be randomized (block randomization, sealed opaque envelopes) into 2 groups: group A (retropupillary iris-claw IOL) and group B (scleral-sutured IOL). Preoperative, intraoperative, and postoperative data will be collected at day 1, day 15, day 30, and day 90. The primary outcomes are best-corrected visual acuity and lens-induced astigmatism at 3 months. Secondary outcomes include IOL centration or tilt, intraoperative and postoperative complications, and patient satisfaction (assessed using the National Eye Institute Visual Function Questionnaire-25). Data will be analyzed using ANOVA and mixed-effects models. Results Recruitment commenced in March 2025 and is expected to conclude by September 2025, with interim data analysis scheduled for November 2025. As of the current submission, patient enrollment is ongoing, and no interim results have been analyzed. Conclusions This randomized protocol is designed to generate comparative clinical evidence on the efficacy, safety, and visual stability of iris-claw and scleral-sutured IOL fixation in primary cataract surgery. The findings will contribute to optimizing surgical decision-making in cases with deficient posterior capsular support.