NCT06450470

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

Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Keratoconus

Interventions

Type	Name	Description
DEVICE	Therapeutic lens alone	Therapeutic lens will be apposed on the patient's eye after crosslinking. Therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.
COMBINATION_PRODUCT	Therapeutic lens + amniotic membrane (Visio-AMTRIX)	Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on the patient's eye after crosslinking. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-06-10
• Last updated: 2025-04-11

Locations

9 sites across 1 country: France