Actively Recruiting
PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2026-01-28
50
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-40 years
- Diagnosed with keratoconus, ABCD Belin stage I-III at baseline
- Minimum corneal thickness (thinnest pachymetry) at least 450 micrometers before surgery
- Provided written informed consent
- For ages 18-25 years: keratoconus stage I-III (progression not required)
- For ages 25-35 years: documented progression or high-risk features for progression
- For ages 35-40 years: clear recent progression or late-onset documented progression may be considered
You will not qualify if you...
- Presence of central corneal scars or opacities
- Prior eye surgery or trauma (except prior LASIK if causing post-surgical ectasia as per protocol)
- Autoimmune disease or uncontrolled diabetes mellitus
- Pregnancy or breastfeeding
- Wearing contact lenses within 2 weeks before baseline evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico City, Mexico, 06800
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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