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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Epi-on PiXL for the Treatment of Progressive Keratoconus.

NCT04668924

Keratoconus Corneal Crosslinking Corneal Densitometry +3 more

ACTIVE_NOT_RECRUITING NA

Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

NCT03858036

Keratoconus Ectasia

UNKNOWN PHASE3

Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

NCT03500796

Corneal Perforation

COMPLETED NA

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

NCT06753916

Corneal Transplant Failure

RECRUITING PHASE2

Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)

NCT02168790

Corneal Ulcers Corneal Melting

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Progressive Keratoconus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapeutic lens alone

Group Type ACTIVE_COMPARATOR

Therapeutic lens alone

Intervention Type DEVICE

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.

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Group Type EXPERIMENTAL

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Intervention Type COMBINATION_PRODUCT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Man or woman between 18 and 65 years old.
* Indication for accelerated conventional crosslinking.
* Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
* Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
* Patient with a minimum corneal thickness greater than 400 microns.
* Informed and consenting patient.
* Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
* Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
* Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria

* Woman without effective means of contraception, pregnant or breastfeeding.
* Patient who has already benefited from a crosslinking procedure on one of the eyes.
* Patient with a history of refractive surgery on one of the eyes.
* Patient with an intracorneal ring segment on one of the eyes.
* Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
* Patient with a psychiatric pathology.
* Patient on long-term analgesics and/or corticosteroids.
* Indication of crosslinking outside the classic protocol.
* Patient with central corneal opacity.
* Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
* Patient with a history of ocular herpes.
* Patient with a history of ocular varicella-zoster virus infection.
* Patient with glaucoma.
* Patient treated with topical cyclosporine in the last 6 months.
* Patient deprived of liberty by a judicial or administrative decision.
* Patient subject to a legal protection measure or unable to express their consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No