Actively Recruiting

Phase Not Applicable
Age: 10Years - 40Years
All Genders
NCT05676580

Risk Factors and Progression of Keratoconus

Led by University Hospital, Montpellier · Updated on 2025-09-05

200

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

Risk Factors and Progression of Keratoconus

Who Can Participate

Age: 10Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants diagnosed with clinical keratoconus or preclinical/crude keratoconus based on topography and slit lamp examination
  • Participants followed by ophthalmology departments at CHU Montpellier, CHU Bordeaux, or CHU Toulouse
  • Adults must provide written informed consent after a reflection period
  • For minors, informed consent must be signed by at least one parent or legal guardian, and the child must assent after a reflection period
  • Participants must be affiliated with the French social security system or be beneficiaries of such a system
Not Eligible

You will not qualify if you...

  • Individuals under legal supervision, guardianship, or curatorship
  • History of corneal implant surgery on both eyes
  • Planned relocation before completing the initial treatment stage (abstention, cross-linking, or intra-corneal ring)

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Gui de Chauliac - Service d'Ophtamologie

Montpellier, Occitanie, France, 34295

Actively Recruiting

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Research Team

V

Vincent DAIEN, PR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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