NCT07372911 PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
| NCT ID | NCT07372911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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: 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
Frequently Asked Questions
Who can join the NCT07372911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07372911 currently recruiting?
Yes, NCT07372911 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto de Oftalmología Fundación Conde de Valenciana to inquire about joining.
Where is the NCT07372911 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07372911 clinical trial?
NCT07372911 is sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. The trial plans to enroll 50 participants.