Comparison of preoperative 5% povidone-iodine plus moxifloxacin versus 5% povidone-iodine alone on ocular surface bacterial flora: protocol for a randomized controlled trial.

Abstract

Background: Acute postoperative endophthalmitis remains a rare but devastating complication of cataract surgery, most commonly arising from organisms originating in the patient's conjunctival flora. While preoperative instillation of 5% povidone-iodine is universally accepted as standard prophylaxis, the additional benefit of preoperative topical antibiotics remains uncertain, particularly in settings with rising antimicrobial resistance and heterogeneous surgical practices. This study aims to determine whether the addition of topical moxifloxacin to 5% povidone-iodine increases the microbiological conversion rate from culture-positive to culture-negative conjunctival status immediately before cataract surgery, compared with 5% povidone-iodine alone.

Methods: This is a single-centre, parallel-group, superiority randomised controlled trial conducted at the University College Hospital, Ibadan, Nigeria. A total of 234 participants scheduled for elective cataract surgery will be randomised (1:1) to receive either preoperative topical moxifloxacin plus povidone-iodine or povidone-iodine alone. Conjunctival swabs will be collected at baseline and immediately prior to surgery. The primary outcome is the proportion of baseline culture-positive eyes that convert to culture-negative status before surgery. Secondary outcomes include residual culture positivity, bacterial species distribution, and antimicrobial susceptibility patterns. Effect estimates will be reported with 95% confidence intervals.

Discussion: This study is expected to clarify whether adjunctive topical moxifloxacin confers additional microbiological benefit beyond povidone-iodine alone. The findings will provide context-specific evidence to inform preoperative prophylactic strategies for cataract surgery, with implications for antimicrobial stewardship and evidence-based surgical guidelines.

Trial registration: Pan African Clinical Trials Registry (PACTR202509780471457). Prospectively registered; URL: https://pactr.samrc.ac.za/ .

Trial status: The trial is still recruiting patients. Recruitment began on September 29, 2025, and is expected to be completed by late March.

Protocol version: Version 1.0, dated 16 July 2025.