Trial reportInternational ophthalmology2026
Evaluation of the clinical efficacy of accelerated photoactivated chromophore for keratitis-CXL for early to mid-stage fungal keratitis: a prospective, multicenter randomized controlled trial.
Trial report in International ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
12 authors.
Funding
Abstract
purposeTo evaluate the clinical efficacy of accelerated photoactivated chromophore for keratitis-corneal collagen cross‑linking (PACK‑CXL) in early‑ to mid‑stage fungal keratitis.
methodsThis multicenter, prospective, randomized trial with masked outcome assessment enrolled patients with early‑ to mid‑stage fungal keratitis, randomizing them to either combined PACK‑CXL plus systemic and topical antifungals (CXL + M) or systemic and topical antifungals alone (M). Standardized examinations were performed at baseline and follow‑up visits. Five co‑primary endpoints (best‑corrected visual acuity, time to clinical healing, fungal density on confocal microscopy, time to clinical improvement, and corneal ulcer area) were assessed with Bonferroni correction (α = 0.01).
resultsA total of 49 patients were enrolled in this study. The CXL + M group showed superior efficacy on four co‑primary endpoints. Median time to clinical cure was halved (30 vs. 60 days; HR 2.76, 95% CI 1.40-5.44; P = 0.003), and median time to clinical improvement reduced from 14 to 7 days (HR 2.61, 95% CI 1.33-5.11; P = 0.005). Total disease burden (AUC for ulcer area and fungal density) was significantly lower (both P ≤ 0.003). BCVA change at 1 month did not differ between groups (P = 0.771). Corneal transplantation rate was lower in CXL + M (4.17% vs. 28.00%; P = 0.049). No adverse events occurred.
conclusionsThis first RCT demonstrates that adjuvant accelerated PACK‑CXL significantly hastens clinical recovery, reduces disease burden and corneal transplantation rate, and shortens healing time in mild-to-moderate fungal keratitis, with a favorable safety profile.
trial registrationThe trial was registered on the Chinese Clinical Trial Registry ( www.chictr.org.cn , ChiCTR2000034467) and recorded with the National Medical Research Registration Information System, under the record number: MR-11-21-014401.
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