Keratoconus Clinical Trials

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Risk Factors and Progression of Keratoconus

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Gui de Chauliac - Service d'Ophtamologie
RECRUITING
Montpellier
Contact Information
Primary
Vincent DAIEN, PR
v-daien@chu-montpellier.fr
0673055877
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 200
Treatments
Other: Abstention
After keratoconus diagnosis the patient won't be assigned to intervention
Other: Intervention (cross-linking surgery or intra corneal ring)
After keratoconus diagnosis the patient was assigned to cross linking surgery or intra corneal ring surgery
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov