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PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Summary
Keratoconus causes irregular astigmatism and reduced vision. Epi-off corneal crosslinking (CXL) stabilizes the cornea but often leaves higher-order aberrations uncorrected. This randomized, parallel-group trial compares corneal wavefront guided photorefractive keratectomy (corneal wavefront guided PRK, 50 µm therapeutic ablation) combined with accelerated epi-off CXL versus epi-off CXL with epithelial removal by phototherapeutic keratectomy (PTK) using a Schwind AMARIS excimer laser, in adults with keratoconus. The primary endpoint is change in best-corrected distance visual acuity (logMAR) at 12 months. Key secondary endpoints include Kmax, corneal higher-order aberrations, manifest refraction, Scheimpflug densitometry (haze) and Fantes grade, Corvis ST biomechanics, NEI VFQ-25, and endothelial cell density by non-contact specular microscopy at 1, 3, 6 and 12 months.
Official title: Corneal Wavefront Guided PRK Combined With Epi-off Corneal Cross-Linking Versus Epi-off Corneal Cross-Linking With PTK Epithelial Removal in Keratoconus: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-09-01
Completion Date
2027-12-30
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
Schwind AMARIS excimer laser
Used for corneal wavefront guided PRK therapeutic ablation (50 µm) or for PTK epithelial removal, according to arm assignment.
Corneal collagen crosslinking epi-off accelerated
Riboflavin-UVA crosslinking performed after epithelial removal (corneal wavefront guided PRK arm via PRK; comparator arm via PTK). Intensity: 30 mW/cm² (pulsed 1 s on / 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J/cm². Total time (elapsed): 6 minutes \[equivalent to 3 minutes "on" time\].
Locations (1)
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico City, Mexico