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Risk Factors and Progression of Keratoconus

RecruitingNAAges 10 Years - 40 YearsAllUniversity Hospital, Montpellier
NCT05676580 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 behavio

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📋 Eligibility rules (as published)
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)
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What it tests

  • cross-linking surgery or intra corneal ring
  • abstention
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Where

1 site
CHU Gui de Chauliac - Service d'Ophtamologie
Montpellier, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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