Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis
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, Pondich...
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| Published in: | Cornea Vol. 40; no. 7; pp. 837 - 841 |
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| Main Authors: | , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Cornea
01-07-2021
Copyright Wolters Kluwer Health, Inc. All rights reserved |
| Online Access: | Get full text |
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| Summary: | 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. |
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| Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 |
| ISSN: | 0277-3740 1536-4798 |
| DOI: | 10.1097/ICO.0000000000002510 |