Study Stopped
Lack of apparent benefits
Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
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)
2 other identifiers
interventional
9
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2022
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2022
CompletedDecember 7, 2022
December 1, 2022
6 months
February 9, 2022
December 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 1
Secondary Outcomes (5)
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
2 days, 3 days, 30 to 45 days
Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
1 day, 2 days, 3 days, 30 to 45 days
Identical healing of both eyes
2 or 3 days, 30 to 45 days
Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
30 to 45 days
Rate of corneal haze for each treatment
30 to 45 days
Study Arms (2)
Therapeutic lens alone
ACTIVE COMPARATORTherapeutic lens + amniotic membrane (Visio-AMTRIX)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Clinique Vision Laser des Alpes
Grenoble, 38000, France
Centre Monticelli-Paradis d'Ophtalmologie
Marseille, 13006, France
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 21, 2022
Study Start
January 25, 2022
Primary Completion
July 21, 2022
Study Completion
July 21, 2022
Last Updated
December 7, 2022
Record last verified: 2022-12