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Original Investigation
Clinical Trial
October 2016

Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With KeratoconusA Randomized Clinical Trial

Author Affiliations
  • 1Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
  • 2Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria
  • 3Department of Ophthalmology, Medical University of Warsaw, Warsaw, Poland
  • 4Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria
  • 5Department of Ophthalmology, Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania
JAMA Ophthalmol. 2016;134(10):1169-1176. doi:10.1001/jamaophthalmol.2016.3019
Key Points

Question  Does a new matrix therapy agent improve corneal wound healing after standard corneal epithelium-off (epi-off) collagen cross-linking (CXL) in patients with keratoconus?

Findings  In a randomized clinical trial of 40 patients with keratoconus scheduled for epi-off CXL, corneal wound healing was significantly faster in patients receiving matrix therapy agent–containing eyedrops compared with control individuals receiving hyaluronic acid–containing eyedrops.

Meaning  Data from this study suggest that a matrix therapy agent improves corneal wound healing after standard corneal epi-off CXL in patients with keratoconus.

Abstract

Importance  Corneal abrasions are frequent after standard (epithelium-off [epi-off]) corneal collagen cross-linking (CXL) in patients with progressive keratoconus. A new matrix therapy agent (ReGeneraTing Agent [RGTA]) has been developed to promote corneal wound healing.

Objective  To assess the effect of the new type of matrix therapy agent on corneal wound healing after epi-off CXL in patients with keratoconus.

Design, Setting, and Participants  This double-masked randomized clinical trial enrolled 40 patients with keratoconus undergoing epi-off CXL from July 18, 2014, to October 21, 2015, when the last follow-up was completed. The analysis of the intention-to-treat population was performed at the Department of Clinical Pharmacology in cooperation with the Center for Medical Physics and Biomedical Engineering and the Department of Ophthalmology and Optometry of the Medical University of Vienna.

Interventions  Patients were randomized to receive the matrix therapy agent or hyaluronic acid–containing eyedrops, 0.1%, every other day starting immediately after surgery. The size of the corneal defect was measured using ultrahigh-resolution optical coherence tomography (OCT) and slitlamp photography (SLP) with fluorescein staining.

Main Outcomes and Measures  Corneal wound healing rate, defined as the size of the defect over time.

Results  Among the 40 patients undergoing epi-off CXL (31 men; 9 women; mean [SD] age, 31 [10] years), wound healing was significantly faster in the matrix therapy agent group compared with the hyaluronic acid group (4.4 vs 6.1 days; mean difference, 1.7 days; 95% CI, 0.25-3.15 days; P = .008). The defect size was smaller in the matrix therapy agent group than in the hyaluronic acid group as measured with OCT (12.4 vs 23.9 mm2; mean difference, 11.6 mm2; 95% CI, 0.8-23.5 mm2; P = .045) and SLP (11.9 vs 23.5 mm2; mean difference, 11. 6 mm2; 95% CI, 1.3-22.9 mm2; P = .03). A correlation between the defect size measured with OCT and SLP was found (r = 0.89; P < .001). No ocular or serious adverse events occurred.

Conclusions and Relevance  Use of a new matrix therapy agent appears to improve corneal wound healing after CXL in patients with keratoconus. Monitoring of corneal wound healing using ultrahigh-resolution OCT might be an attractive alternative to SLP because OCT provides an objective and 3-dimensional evaluation of the corneal defect.

Trial Registration  clinicaltrials.gov Identifier: NCT02119039

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