RecruitingNot Applicable

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

Mexico50 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-40 years * Diagnosis of keratoconus, ABCD Belin stage I-III at baseline * Minimum (thinnest) corneal pachymetry ≥ 450 µm pre-op * Written informed consent * Age-stratified progression requirements: * 18-25 y: keratoconus stage I-III (progression not mandatory) * 25-35 y: documented progression (meet ≥ 2 Table-1 criteria below) or, if recent documentation is absent, high-risk features for future progression: Kmax \> 53 D, strong family history, severe atopy with persistent eye rubbing, or any of the following over 12 months: ΔKmax ≥ 1.0 D, thinnest pachymetry decrease ≥ 10 µm, or increase in manifest cylinder ≥ 1.0 D * 35-40 y: clear, unequivocal recent progression (meet ≥ 2 Table-1 criteria); late-onset documented progression may be considered Exclusion Criteria: * Central corneal scars or opacities * Prior ocular surgery or trauma (exception: prior LASIK if it is the cause of post-surgical ectasia, per protocol text) * Autoimmune disease or uncontrolled diabetes mellitus * Pregnancy or lactation * Contact lens wear within 2 weeks before baseline evaluation

What they're measuring

Change in best-corrected distance visual acuity (logMAR)

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT07372911

SponsorInstituto de Oftalmología Fundación Conde de Valenciana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01