PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus (NCT07372911) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in best-corrected distance visual acuity (logMAR)
Timeframe: Baseline to 12 months
Trial details
NCT IDNCT07372911
SponsorInstituto de Oftalmología Fundación Conde de Valenciana