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Original Investigation | Clinical Trial

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

Ahmed M. Bata, MD1; Katarzyna J. Witkowska, MD, PhD1,2; Piotr A. Wozniak, MD1,3; Klemens Fondi, MD1; Gerald Schmidinger, MD4; Niklas Pircher, MD4; Stephan Szegedi, MD1; Valentin Aranha dos Santos, MSc2; Anca Pantalon, MD5; René M. Werkmeister, PhD2; Gerhard Garhofer, MD1; Leopold Schmetterer, PhD1,2; Doreen Schmidl, MD, PhD1,2
[+] 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. Published online September 01, 2016. doi:10.1001/jamaophthalmol.2016.3019
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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

Figures in this Article

Figures

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Figure 1.
Study Flowchart

One of the 2 patients lost to follow-up in the matrix therapy agent (MTA) group attended the day 2 postoperative visit and was included in the per protocol analysis.

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Figure 2.
Fluorescein Slitlamp Photographs and Ultrahigh-Resolution Optical Coherence Tomography Images

Images were obtained from patient 15, who was randomized to the matrix therapy agent group.

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Figure 3.
Mean Time to Complete Wound Healing

The control treatment consisted of hyaluronic acid–containing eyedrops. Curved line indicates the normal distribution fit.

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Figure 4.
Change in Area of Defect After Treatment

The control treatment consisted of hyaluronic acid–containing eyedrops. Data were separately measured using slitlamp photography after fluorescein staining or optical coherence tomography. Squares indicate mean area of defect; lines, individual patients.

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Figure 5.
Correlation and Comparison of Area of Defect

A, Correlation between the area of defect as measured using slitlamp photography (SLP) after fluorescein staining and ultrahigh-resolution optical coherence tomography (OCT). Solid line indicates the regression line; dotted lines, 95% CI. B, Bland-Altman plot compares the area of the defect as measured using SLP after fluorescein staining and OCT. Horizontal line indicates the mean difference between OCT and SLP. Data points indicate individual patients.

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