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

Recruiting N/A Interventional Study
Keratoconus
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana · Other
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About This Trial
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 epithe…
Trial Locations
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Eligibility Criteria
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…
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