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

Recruiting now · Not applicable

Conditions studied: Keratoconus

In brief

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.

Key facts

Study ID

NCT07372911

Run by

Instituto de Oftalmología Fundación Conde de Valenciana

People needed

50

Starts

2025-09-01

Expected to finish

2027-12-30

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro — Mexico City, Mexico City, Mexico (enrolling)

Full record on ClinicalTrials.gov

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