Last updated 34 days ago
PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
50 patients around the world
Available in Mexico
Instituto de Oftalmología Fundación Conde de Valenciana
1Research sites
50Patients around the world
This study is for people with
Keratoconus
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Recruiting
StudyPRoTECT
SponsorInstituto de Oftalmología Fundación Conde de Valenciana
Study typeInterventional
Conditions
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07372911
