Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus (NCT06450470) is a Phase 3 interventional studying Progressive Keratoconus, sponsored by TBF Genie Tissulaire. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Progressive Keratoconus, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 116 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Progressive Keratoconus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form of the French Ophthalmology Society for crosslinking. - Patient affiliated to a social security system or beneficiary of such a system. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06450470), the sponsor (TBF Genie Tissulaire), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06450470 clinical trial studying?

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 full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06450470?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06450470?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06450470. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06450470. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.