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Study identifier: NCT07372911 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

Condition: Keratoconus  ·  Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

PhaseNA
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Locations (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede CentroMexico City, Mexico City, MexicoRecruiting

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Source record: clinicaltrials.gov/study/NCT07372911