PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus (NCT07372911)
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
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro — Mexico City, Mexico City
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro — Mexico City, Mexico City
📞 Contact the Study Coordinator
Phone: (331) 466-2291
Email: jc.guerrero1226@gmail.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Keratoconus
- Initial Correction Keratoconus — Chicago, Illinois
- McNeel Eye Center Corneal Crosslinking Study — Boise, Idaho
- Assessing Patient Engagement in Keratoconus Clinical Research — San Francisco, California
- Outcomes of CTAK Surgery — Palo Alto, California
- A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients — Boston, Massachusetts
- OCT in Diagnosis of Irregular Corneas — Portland, Oregon
Explore by condition: All Keratoconus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.