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New treatment option for Progressive Keratoconus
Official title Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
ClinicalTrials.gov ID: NCT06450470
What this study is testing
What is Therapeutic lens + amniotic membrane (Visio-AMTRIX)?
Therapeutic lens + amniotic membrane (Visio-AMTRIX) is an investigational medicine, being studied as a potential treatment for progressive keratoconus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Saint-Priest-en-Jarez, France
- Strasbourg, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Lyon, France; Marseille, France; Montpellier, France; Nantes, France; Paris, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.