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

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-07-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myopia Astigmatism Hypermetropia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Self-controlled trial: each patient serves as his or her own control. After bilateral PRK procedure, patients will receive both treatments, one treatment in each eye.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Therapeutic lens alone

Group Type ACTIVE_COMPARATOR

Therapeutic lens alone

Intervention Type OTHER

Therapeutic lens will be apposed on patient's dominant eye after bilateral PRK. Therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Group Type EXPERIMENTAL

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Intervention Type OTHER

Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on patient's non-dominant eye after bilateral PRK. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.

Interventions

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Therapeutic lens alone

Therapeutic lens will be apposed on patient's dominant eye after bilateral PRK. Therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.

Intervention Type OTHER

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on patient's non-dominant eye after bilateral PRK. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No