Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR

TBF Genie Tissulaire

Status and phase: Terminated; Phase 3

Conditions: Myopia; Astigmatism; Hypermetropia

Treatments: Other: Therapeutic lens alone; Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05247658

2021-A01933-38 (Other Identifier)

AMTRIX-PKR-TBF

Details and patient eligibility

About

The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Therapeutic lens alone

Active Comparator group

Treatment:

Other: Therapeutic lens alone

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Experimental group

Treatment:

Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX)