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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Cornea
01-07-2021
Copyright Wolters Kluwer Health, Inc. All rights reserved |
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| 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. |
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| AbstractList | 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. 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. PURPOSETo determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis. METHODSThis 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. RESULTSThose 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. CONCLUSIONSWe 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 REGISTRATIONNCT02570321. |
| Author | Porco, Travis C. Liu, Zijun Lietman, Thomas M. Lalitha, Prajna Prajna, N. Venkatesh Keenan, Jeremy D. Rose-Nussbaumer, Jennifer Narayana, Shivananda Radhakrishnan, Naveen Austin, Ariana F. Rajaraman, Revathi |
| AuthorAffiliation | Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India Francis I. Proctor Foundation, University of California San Francisco, CA |
| AuthorAffiliation_xml | – name: Francis I. Proctor Foundation, University of California San Francisco, CA – name: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India |
| Author_xml | – sequence: 1 givenname: N. Venkatesh surname: Prajna fullname: Prajna, N. Venkatesh organization: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India – sequence: 2 givenname: Naveen surname: Radhakrishnan fullname: Radhakrishnan, Naveen organization: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India – sequence: 3 givenname: Prajna surname: Lalitha fullname: Lalitha, Prajna organization: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India – sequence: 4 givenname: Revathi surname: Rajaraman fullname: Rajaraman, Revathi organization: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India – sequence: 5 givenname: Shivananda surname: Narayana fullname: Narayana, Shivananda organization: Aravind Eye Hospitals, Madurai, Coimbatore, Pondicherry, India – sequence: 6 givenname: Ariana F. surname: Austin fullname: Austin, Ariana F. organization: Francis I. Proctor Foundation, University of California San Francisco, CA – sequence: 7 givenname: Zijun surname: Liu fullname: Liu, Zijun organization: Francis I. Proctor Foundation, University of California San Francisco, CA – sequence: 8 givenname: Jeremy D. surname: Keenan fullname: Keenan, Jeremy D. organization: Francis I. Proctor Foundation, University of California San Francisco, CA – sequence: 9 givenname: Travis C. surname: Porco fullname: Porco, Travis C. organization: Francis I. Proctor Foundation, University of California San Francisco, CA – sequence: 10 givenname: Thomas M. surname: Lietman fullname: Lietman, Thomas M. organization: Francis I. Proctor Foundation, University of California San Francisco, CA – sequence: 11 givenname: Jennifer surname: Rose-Nussbaumer fullname: Rose-Nussbaumer, Jennifer organization: Francis I. Proctor Foundation, University of California San Francisco, CA |
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| Snippet | PURPOSE:To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis.
METHODS:This is an outcome-masked, randomized... Purpose: To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis. Methods: This is an outcome-masked,... PURPOSETo determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis. METHODSThis is an outcome-masked, randomized... |
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| Title | Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis |
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