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Not Yet Recruiting NCT05676580

Risk Factors and Progression of Keratoconus

Conditions: Keratoconus

Sex: All
Ages: 10 Years – 40 Years
Phase: NA
Enrollment: 200
Sponsor: University Hospital, Montpellier

Location: France

Summary

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 instructionsAt 1 month in participants assigned to cross-linking surgeryAt 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 .

Eligibility 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 ToulouseFor adult Participants: collection of written informed consent, after a period of reflection periodFor 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 reflectionAffiliation to the French social security system or beneficiary of such a systemExclusion Criteria:Person under legal supervision, guardianship or curatorHistory of corneal implant on both eyesPlanned relocation before the end of the first stage of treatment (abstention, cross-linking, intra-corneal ring depending on the participant)

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Source: ClinicalTrials.gov (NCT05676580). StuddyBuddy aggregates publicly available trial information.