Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis.

Abstract

PURPOSE:

To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis.

METHODS:

This is an outcome-masked, randomized controlled clinical trial. Consecutive patients presenting with a smear-positive bacterial ulcer at Aravind Eye Hospitals at Madurai, Pondicherry, and Coimbatore in India were enrolled. Study eyes were randomized to topical moxifloxacin 0.5% or topical moxifloxacin 0.5% plus CXL. The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events.

RESULTS:

Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI]: 0.10-3.50; P = 0.65), 0.9 logarithm of the minimum angle of resolution lines worse visual acuity (95% CI: -2.8 to 4.6; P = 0.63), and 0.41-mm larger scar size (95% CI: -0.48 to 1.30; P = 0.38) at 3 months. We note fewer corneal perforations or need for therapeutic penetrating keratoplasty in the CXL group.

CONCLUSIONS:

We were unable to confirm a benefit to adjuvant CXL in the primary treatment of moderate bacterial keratitis. However, CXL may reduce culture positivity and complication rates; therefore, a larger trial to fully evaluate this is warranted.

TRIAL REGISTRATION:

NCT02570321.

• Authors: N Venkatesh Prajna, Naveen Radhakrishnan, Prajna Lalitha, Revathi Rajaraman, Shivananda Narayana, Ariana F Austin, Zijun Liu, Jeremy D Keenan, Travis C Porco, Thomas M Lietman, Jennifer Rose-Nussbaumer
• Journal: Cornea (Cornea) Vol. 40 Issue 7 Pg. 837-841 (Jul 01 2021) ISSN: 1536-4798 [Electronic] United States
• PMID: 33079921 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Chemical References

• Anti-Bacterial Agents
• Cross-Linking Reagents
• Photosensitizing Agents
• Collagen
• Riboflavin
• Moxifloxacin

Topics

• Aged
• Anti-Bacterial Agents (therapeutic use)
• Bacteria (isolation & purification)
• Collagen (metabolism)
• Combined Modality Therapy
• Corneal Stroma (drug effects, metabolism)
• Corneal Ulcer (drug therapy, metabolism, microbiology, physiopathology)
• Cross-Linking Reagents (therapeutic use)
• Eye Infections, Bacterial (drug therapy, metabolism, microbiology, physiopathology)
• Female
• Humans
• Male
• Middle Aged
• Moxifloxacin (therapeutic use)
• Photochemotherapy (methods)
• Photosensitizing Agents (therapeutic use)
• Riboflavin (therapeutic use)
• Treatment Outcome
• Ultraviolet Rays
• Visual Acuity (physiology)