Sherwin J Isenberg1, Leonard Apt2, Mario Valenton3, Savitri Sharma4, Prashant Garg4, Philip A Thomas5, Pragya Parmar5, Jayaraman Kaliamurthy5, Johann M Reyes3, Daniel Ong3, Peter D Christenson6, Madeline Del Signore7, Gary N Holland8. 1. Center To Prevent Childhood Blindness, UCLA Stein Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California; Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California. 2. Center To Prevent Childhood Blindness, UCLA Stein Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. 3. Philippine General Hospital, Manila, Philippines. 4. L.V. Prasad Eye Institute, Hyderabad, India. 5. Joseph Eye Hospital, Tiruchirapalli, India. 6. Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California; Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California. 7. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California. 8. Ocular Inflammatory Disease Center, UCLA Stein Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: uveitis@jsei.ucla.edu.
Abstract
PURPOSE: To compare povidone-iodine 1.25% ophthalmic solution with topical antibiotics for treatment of bacterial keratitis in areas of the world where use of effective topical antibiotics may not be an option. STUDY DESIGN: Randomized, controlled, investigator-masked clinical trial. METHODS: We randomized 172 individuals with bacterial keratitis to topical treatment withpovidone-iodine or antibiotics (neomycin-polymyxin B-gramicidin in the Philippines; ciprofloxacin 0.3% in India). Using survival analysis, we compared intervals from start of treatment to "presumed cure" (primary outcome measure, defined as a closed epithelial defect without associated inflammatory signs) and to "recovering" (residual epithelial defect <1 mm2 with only minimal inflammation). RESULTS:Median interval to presumed cure in the Philippines was 7 days for povidone-iodine and 7 days for neomycin-polymyxin B-gramicidin (95% confidence interval [CI] for difference in median interval, -9.5 to 0.7 days) and in India was 12 days for povidone-iodine and 17 days for ciprofloxacin (95% CI, -35.2 to 3.2 days). Hazard ratio (HR) for presumed cure among those treated with povidone-iodine (vs antibiotics) was 1.46 in the Philippines (95% CI, 0.90-2.36; P = .13) and 1.70 in India (95% CI, 0.73-3.94; P = .22). Comparisons of intervals to recovering and HR for recovering also revealed no significant differences between treatment groups in either country. CONCLUSIONS: There is no significant difference between the effect of topical povidone-iodine 1.25% and topical antibiotics commonly available in the developing world for treatment of bacterial keratitis. Povidone-iodine 1.25%, which is widely available and inexpensive, can be considered for treatment of bacterial keratitis when antibiotic treatment is not practical. Published by Elsevier Inc.
RCT Entities:
PURPOSE: To compare povidone-iodine 1.25% ophthalmic solution with topical antibiotics for treatment of bacterial keratitis in areas of the world where use of effective topical antibiotics may not be an option. STUDY DESIGN: Randomized, controlled, investigator-masked clinical trial. METHODS: We randomized 172 individuals with bacterial keratitis to topical treatment with povidone-iodine or antibiotics (neomycin-polymyxin B-gramicidin in the Philippines; ciprofloxacin 0.3% in India). Using survival analysis, we compared intervals from start of treatment to "presumed cure" (primary outcome measure, defined as a closed epithelial defect without associated inflammatory signs) and to "recovering" (residual epithelial defect <1 mm2 with only minimal inflammation). RESULTS: Median interval to presumed cure in the Philippines was 7 days for povidone-iodine and 7 days for neomycin-polymyxin B-gramicidin (95% confidence interval [CI] for difference in median interval, -9.5 to 0.7 days) and in India was 12 days for povidone-iodine and 17 days for ciprofloxacin (95% CI, -35.2 to 3.2 days). Hazard ratio (HR) for presumed cure among those treated with povidone-iodine (vs antibiotics) was 1.46 in the Philippines (95% CI, 0.90-2.36; P = .13) and 1.70 in India (95% CI, 0.73-3.94; P = .22). Comparisons of intervals to recovering and HR for recovering also revealed no significant differences between treatment groups in either country. CONCLUSIONS: There is no significant difference between the effect of topical povidone-iodine 1.25% and topical antibiotics commonly available in the developing world for treatment of bacterial keratitis. Povidone-iodine 1.25%, which is widely available and inexpensive, can be considered for treatment of bacterial keratitis when antibiotic treatment is not practical. Published by Elsevier Inc.