Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
Launched by TBF GENIE TISSULAIRE · Feb 9, 2022
Trial Information
Current as of May 18, 2025
Terminated
Keywords
ClinConnect Summary
Photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) are two of the most widely used techniques of laser vision correction. However, one of the major disadvantages of the PRK technique is the pain experienced during 1 to 3 days after intervention.
Preliminary data on a limited number of patients tend to show a reduction of pain, tearing and discomfort in patients for whom a amniotic membrane was used under a therapeutic lens.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female, aged 18 to 80 years.
- • Patient undergoing bilateral PRK procedure for myopia, astigmatism or hypermetropia with technique chosen for one of the following reasons: thin cornea, irregular cornea, suspected keratoconus, practice of combat or contact sports, professional activity at risk of direct impact.
- • Patient understanding french language.
- • Patient who received the study information and provided written consent to participation in the study.
- • Patient who is a member or a beneficiary of a national health insurance plan.
- Exclusion Criteria:
- • Pregnant woman.
- • Patient with a contraindication to PRK.
- • Diabetic patient.
- • Patient allergic to Oxybuprocaine and / or Tetracaine eye drops, to local anesthetics or to fluorescein.
- • Monophthalmic patient.
- • Person deprived of liberty by a judicial or administrative decision.
- • Adult subjected to a legal protection measure or unable to express his / her consent.
About Tbf Genie Tissulaire
TBF Genie Tissulaire is a pioneering clinical trial sponsor dedicated to advancing the field of regenerative medicine through innovative tissue engineering solutions. With a focus on developing cutting-edge therapies that harness the body's natural healing processes, TBF Genie Tissulaire collaborates with leading researchers and institutions to conduct rigorous clinical trials aimed at improving patient outcomes. The organization is committed to adhering to the highest ethical standards and regulatory requirements, ensuring that all research initiatives are conducted with integrity and transparency. By leveraging state-of-the-art technology and a multidisciplinary approach, TBF Genie Tissulaire strives to bring transformative treatments to market that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Priest En Jarez, , France
Grenoble, , France
Marseille, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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