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

Primary Purpose

Myopia, Astigmatism, Hypermetropia

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Therapeutic lens alone
Therapeutic lens + amniotic membrane (Visio-AMTRIX)
Sponsored by
TBF Genie Tissulaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia focused on measuring PhotoRefractive Keratectomy (PRK)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinique Vision Laser des Alpes
  • Centre Monticelli-Paradis d'Ophtalmologie
  • CHU de Saint-Etienne Hôpital Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Therapeutic lens alone

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Arm Description

Outcomes

Primary Outcome Measures

Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes

Secondary Outcome Measures

Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Evaluation by the patient of visual discomfort criteria; tearing, foreign body sensation, blurred vision, and photophobia; from 0: no discomfort to 10: worst imaginable discomfort on visual analog scale (VAS) in both eyes
Identical healing of both eyes
Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size
Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes
Rate of corneal haze for each treatment
Evaluation of presence of corneal haze through the Hanna's grading scale from grade 0: no haze to grade 4: very severe haze

Full Information

First Posted
February 9, 2022
Last Updated
December 5, 2022
Sponsor
TBF Genie Tissulaire
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1. Study Identification

Unique Protocol Identification Number
NCT05247658
Brief Title
Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
Official Title
Study Comparing a Therapeutic Lens Used Alone to a Therapeutic Lens Used in Association With an Amniotic Membrane Treated by the AMTRIX Process in Postoperative Care After Photorefractive Keratectomy (PRK)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of apparent benefits
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism, Hypermetropia
Keywords
PhotoRefractive Keratectomy (PRK)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic lens alone
Arm Type
Active Comparator
Arm Title
Therapeutic lens + amniotic membrane (Visio-AMTRIX)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Therapeutic lens alone
Intervention Description
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
Intervention Name(s)
Therapeutic lens + amniotic membrane (Visio-AMTRIX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Description
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Description
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Time Frame
2 days, 3 days, 30 to 45 days
Title
Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Description
Evaluation by the patient of visual discomfort criteria; tearing, foreign body sensation, blurred vision, and photophobia; from 0: no discomfort to 10: worst imaginable discomfort on visual analog scale (VAS) in both eyes
Time Frame
1 day, 2 days, 3 days, 30 to 45 days
Title
Identical healing of both eyes
Description
Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size
Time Frame
2 or 3 days, 30 to 45 days
Title
Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Description
Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes
Time Frame
30 to 45 days
Title
Rate of corneal haze for each treatment
Description
Evaluation of presence of corneal haze through the Hanna's grading scale from grade 0: no haze to grade 4: very severe haze
Time Frame
30 to 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clinique Vision Laser des Alpes
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Monticelli-Paradis d'Ophtalmologie
City
Marseille
ZIP/Postal Code
13006
Country
France
Facility Name
CHU de Saint-Etienne Hôpital Nord
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France

12. IPD Sharing Statement

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

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