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Purpose <p>To evaluate the clinical efficacy of accelerated photoactivated chromophore for keratitis–corneal collagen cross‑linking (PACK‑CXL) in early‑ to mid‑stage fungal keratitis.</p> Methods <p>This 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).</p> Results <p>A 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&#xa0;days; HR 2.76, 95% CI 1.40–5.44; <i>P</i> = 0.003), and median time to clinical improvement reduced from 14 to 7&#xa0;days (HR 2.61, 95% CI 1.33–5.11; <i>P</i> = 0.005). Total disease burden (AUC for ulcer area and fungal density) was significantly lower (both <i>P</i> ≤ 0.003). BCVA change at 1&#xa0;month did not differ between groups (<i>P</i> = 0.771). Corneal transplantation rate was lower in CXL + M (4.17% vs. 28.00%; <i>P</i> = 0.049). No adverse events occurred.</p> Conclusions <p>This 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.</p> Trial registration <p>The trial was registered on the Chinese Clinical Trial Registry (<a href="http://www.chictr.org.cn">www.chictr.org.cn</a>, ChiCTR2000034467) and recorded with the National Medical Research Registration Information System, under the record number: MR-11-21-014401.</p>

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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

  • 期刊论文

  • 发表日期：

    2026年7月18日

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  • Xingli Zhou,
  • Chang Liu,
  • Tiehong Chen,
  • Qingyan Zeng,
  • Sangchao Wu,
  • Yi Ren,
  • Jing Lu,
  • Jie Bai,
  • Ling Li,
  • Ling Zhao,
  • Luping Hu,
  • Shaowei Li

摘要

Purpose

To evaluate the clinical efficacy of accelerated photoactivated chromophore for keratitis–corneal collagen cross‑linking (PACK‑CXL) in early‑ to mid‑stage fungal keratitis.

Methods

This 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).

Results

A 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.

Conclusions

This 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 registration

The 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.