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PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus | Clinical Trials | Clareo Health

RECRUITINGNA

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

Corneal Wavefront Guided PRK Combined With Epi-off Corneal Cross-Linking Versus Epi-off Corneal Cross-Linking With PTK Epithelial Removal in Keratoconus: A Randomized Clinical Trial

NCT07372911•Instituto de Oftalmología Fundación Conde de Valenciana

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, Mexico City, Mexico

Key Dates

Start Date

September 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 30, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Keratoconus

Interventions

Schwind AMARIS excimer laser

DEVICE

Corneal collagen crosslinking epi-off accelerated

PROCEDURE

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

NCT06451718

Keratoconus

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RECRUITING

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

NCT02118922

KeratoconusEctasia+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Scleral Lens Fitting Using Wide-Field OCT

OCT in Diagnosis of Irregular Corneas

Clinical Investigation for a Multifunction Ophthalmic Measurement Device