Vision-Related Quality of Life Outcomes in Patients Treated for Filamentous Fungal Keratitis in the CLAIR Trial

Abstract

Purpose To analyze vision-related quality of life in patients with fungal keratitis treated with topical antifungal medications and adjuvant crosslinking in the Cross-Linking Assisted Infection Reduction (CLAIR) trial Methods Study participants were randomized to one of four treatment combinations: (1) topical natamycin 5%, (2) topical natamycin 5% plus CXL, (3) topical amphotericin 0.15%, and (4) topical amphotericin 0.15% plus CXL. All participants responded to the Indian visual function questionnaire (IND-VFQ) at the baseline visit and 3 months after enrollment. Responses were averaged within four subscales (mobility, activity limitation, psychosocial impact, and visual function). Scores were compared between the acute phase of infection and after treatment. Linear regressions were then performed to compare IND-VFQ results between the four arms. Results IND-VFQ scores improved in patients three months after initiating treatment compared to baseline (P<0.01). Participants treated with amphotericin had a VFQ score 2.60 points (95% CI, -6.90-12.10) higher than those treated with natamycin (P=0.59). Participants treated with CXL had an average VFQ score 4.15 points (95% CI, -5.43-13.70) higher than those treated with medication only (P=0.29). Subscale analysis did not show significant differences between treatment groups. Conclusions All patients reported improved vision-related quality of life after treatment of fungal keratitis. Treatment with natamycin and amphotericin B produced similar results. Primary adjunctive CXL did not benefit patients with respect to vision-related quality of life in fungal keratitis patients. These results reflected primary results of CLAIR regarding microbiological cure, infiltrate and/or scar size, percent epithelialization, and frequency of adverse events.