RecruitingPhase 3NCT06450470

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


Sponsor

TBF Genie Tissulaire

Enrollment

116 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Therapeutic lens + amniotic membrane (Visio-AMTRIX) and a medical device called Therapeutic lens alone for people with progressive keratoconus. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETherapeutic 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_PRODUCTTherapeutic 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.


Locations(9)

CHU de Brest

Brest, France

Hospices Civils de Lyon

Lyon, France

Assistance Publique - Hôpitaux de Marseille

Marseille, France

CHU de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

Hôpital National de la Vision des Quinze-Vingts

Paris, France

CHU de Saint-Etienne

Saint-Priest-en-Jarez, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06450470


Related Trials