NCT05676580 Risk Factors and Progression of Keratoconus
| NCT ID | NCT05676580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2027-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-06-05 with a primary completion date of 2027-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 .
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 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)
Contact & Investigator
Vincent DAIEN, PR
PRINCIPAL INVESTIGATOR
CHU Monptellier
Frequently Asked Questions
Who can join the NCT05676580 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 40 Years, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05676580 currently recruiting?
Yes, NCT05676580 is actively recruiting participants. Contact the research team at v-daien@chu-montpellier.fr for enrollment information.
Where is the NCT05676580 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05676580 clinical trial?
NCT05676580 is sponsored by University Hospital, Montpellier. The principal investigator is Vincent DAIEN, PR at CHU Monptellier. The trial plans to enroll 200 participants.