Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

Risk Factors and Progression of Keratoconus

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Primary objective : Description of keratoconus at baseline and during progression in 200 participants followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. Clinical outcome, histology of the cornea and tears proteomics will be assessed in 4 groups at different points in time: * At 6 months in participants with no intervention (risk reduction instructions: not to rub their eyes) * At 6 months in participants with no intervention that didn't comply with the risk reduction instructions * At 1 month in participants assigned to cross-linking surgery * At 1 month in participants assigned to intra corneal ring surgery If both eyes are affected, both will be evaluated with their own visit agenda. Visits for no surgery participants will be set at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction). Visits for surgery participants will be set at D7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring. Secondary objective : Description of the association between clinical outcomes, histological progression of the cornea and tears proteomics in time, 2 years period. Comparison of tears proteomics in 36 participants with keratoconus followed at CHU of Montpellier and healthy participants at baseline .

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form, after a period of reflection period - For minors: willing to sign a consent form 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

PROCEDURE

cross-linking surgery or intra corneal ring

After keratoconus diagnosis the patient was assigned to surgery

OTHER

abstention

No surgery

Locations (1)

CHU Gui de Chauliac - Service d'Ophtamologie
Montpellier, Occitanie, France