Understanding risk factors and progression of keratoconus
Risk Factors and Progression of Keratoconus
This study is trying to see how keratoconus changes over two years in 200 people with different treatment options, including no treatment, to better understand the condition and its effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 10 Years to 40 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Occitanie) |
| Trial ID | NCT05676580 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the progression of keratoconus in 200 participants over a two-year period, focusing on clinical outcomes, histology of the cornea, and proteomics of tears. Participants will be divided into groups based on their treatment approach, including those receiving no intervention, cross-linking surgery, or intra corneal ring surgery. Follow-up visits will occur at various intervals depending on the assigned treatment, with assessments made at 1, 6, 12, and 24 months. The study will also include a detailed analysis of both eyes if they are affected.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 10 to 40 years with clinical or preclinical keratoconus being followed by the ophthalmology departments of the participating hospitals.
Not a fit: Patients with a history of corneal implants in both eyes or those under legal supervision may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of keratoconus, potentially enhancing patient outcomes.
How similar studies have performed: While this study builds on existing knowledge of keratoconus, its specific approach to evaluating multiple interventions and their effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with clinical keratoconus (Rabinowitz criteria with topographic slit lamp abnormalities and visual impairment), preclinical or crude keratoconus (abnormal or suspicious topography with normal slit lamp examination and normal visual acuity, visual acuity) * Followed by the ophthalmology services of the CHU Montpellier, CHU Bordeaux or CHU Toulouse * For adult Participants: collection of written informed consent, after a period of reflection period * For minors: informed consent signed by at least one of the 2 parents or legal representatives legal representatives, and assent of the child after a period of reflection * Affiliation to the French social security system or beneficiary of such a system Exclusion Criteria: * Person under legal supervision, guardianship or curator * History of corneal implant on both eyes * Planned relocation before the end of the first stage of treatment (abstention, cross-linking, intra-corneal ring depending on the participant)
Where this trial is running
Montpellier, Occitanie
- CHU Gui de Chauliac - Service d'Ophtamologie — Montpellier, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Vincent DAIEN, PR — CHU Monptellier
- Study coordinator: Vincent DAIEN, PR
- Email: v-daien@chu-montpellier.fr
- Phone: 0673055877
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.