drugset / Trial / NCT06450470

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

NCT06450470 ↗

Phase 3 Recruiting 116 enrolled TBF Genie Tissulaire
RandomizedParallel-groupSingle-blindSupportive care

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.

Timeline

Start
2024-11-25
Primary completion
2025-11
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Visio-AMTRIX Other / unclassified — —

Indications