Understanding risk factors and progression of keratoconus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the progression of keratoconus in 200 participants over a two-year period, focusing on clinical outcomes, histology of the cornea, and proteomics of tears. Participants will be divided into groups based on their treatment approach, including those receiving no intervention, cross-linking surgery, or intra corneal ring surgery. Follow-up visits will occur at various intervals depending on the assigned treatment, with assessments made at 1, 6, 12, and 24 months. The study will also include a detailed analysis of both eyes if they are affected.

Why it matters

Who can join: the full rules

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)

Where it's running

• CHU Gui de Chauliac - Service d'Ophtamologie
  Montpellier, Occitanie, France Recruiting

Study contacts

• Principal investigator: Vincent DAIEN, PR — CHU Monptellier
• Study coordinator: Vincent DAIEN, PR
• Email: v-daien@chu-montpellier.fr
• Phone: 0673055877

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia

  This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.

  Recruiting Phase 2/3 Price Vision Group · Indianapolis, Indiana · NCT07841470

• Brillouin hydration mapping to study cornea health

  Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07780890

• Same-day bilateral corneal cross-linking for keratoconus

  This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.

  Recruiting Phase 4 Glaukos Corporation · Westerville, Ohio · NCT07629557

• A Smart Aperture Lens to Help Keratoconus and Presbyopia

  This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.

  Recruiting at 2 sites Azalea Vision · Antwerp and 1 other locations · NCT07559188

• GLK-221 eye drops for keratoconus

  This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.

  Recruiting Phase 2 Glaukos Corporation · Westerville, Ohio · NCT07400952

• Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus

  This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.

  Recruiting Instituto de Oftalmología Fundación Conde de Valenciana · Mexico City, Mexico City · NCT07372911

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.