Personalized corneal cross-linking for thin keratoconus
Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus Corneas
This study is testing a personalized treatment for people with thin keratoconus to see if a gentler corneal cross-linking procedure can help stabilize their vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06159881 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of a customized corneal cross-linking procedure using reduced energy levels in patients diagnosed with keratoconus. The study will focus on individuals with corneal thickness below 400 microns, assessing whether this personalized approach can stabilize corneal ectasia. Participants will undergo the treatment and attend follow-up consultations to monitor their progress and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with keratoconus who have a corneal thickness of less than 400 microns.
Not a fit: Patients with a history of previous corneal cross-linking or those with significant corneal scarring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer treatment option for patients with thin keratoconus, potentially preventing further vision deterioration.
How similar studies have performed: While the approach of personalized energy in corneal cross-linking is innovative, similar studies have shown promise in improving outcomes for keratoconus patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Keratoconus diagnosed with corneal tomography/topography * Thinnest point pachymetry below 400 microns Exclusion Criteria: * Previous corneal cross linking history * Corneal scars not allowing best corrected visual acuity of 20/100 or better * Previous corneal hydrops history * Psychomotor retardation history
Where this trial is running
Mexico City
- Instituto de Oftalmología Conde de Valenciana — Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Itamar Vigderovich, MD
- Email: vigderovich@gmail.com
- Phone: +52 5519491905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.