Clinical Trial

Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

Recruiting Phase 3
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Record status
This record was last updated April 11, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties. The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-04; most recent amendment 2025-04-08.
Status change: Not Yet Recruiting → Recruiting 2024-11-12
Trial Details
NCT Number NCT06450470
Lead Sponsor TBF Genie Tissulaire
Conditions Progressive Keratoconus
Enrollment 116 participants
Start Date 2024-11-25
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-04-11