MyopiaPhase 3NCT05247658
Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
A Phase 3 study testing Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX) in people with Myopia and Astigmatism, run by TBF Genie Tissulaire at 3 sites in France.
Trial summary
The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myopia, Astigmatism, Hypermetropia
- What is being tested?
- Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jan 2022to 21 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Clinique Vision Laser des Alpes
Grenoble, 38000
Centre Monticelli-Paradis d'Ophtalmologie
Marseille, 13006
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, 42270
About this study
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)
The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.
Read the 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.
- Conditions
- Myopia, Astigmatism, Hypermetropia
- Being tested
- Therapeutic lens alone, Therapeutic lens + amniotic membrane (Visio-AMTRIX)
- Keywords
- PhotoRefractive Keratectomy (PRK)
- Medical subject headings
- Myopia, Astigmatism, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic lens aloneOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic lens alone | Active comparator | Not described Receives: Other: Therapeutic lens alone |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental | Not described Receives: Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Measured: 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)
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
Measured: 1 day, 2 days, 3 days, 30 to 45 days
Identical healing of both eyes
Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size
Measured: 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)
Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes
Measured: 30 to 45 days
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
Measured: 30 to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start25 Jan 2022
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Why it stopped: Lack of apparent benefits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247658
- Sponsor's protocol ID
- AMTRIX-PKR-TBF
- Other IDs
- 2021-A01933-38
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05247658
- Acronym / sponsor ID
- AMTRIX-PKR-TBF
- Conditions
- Myopia, Astigmatism, Hypermetropia
- Keywords
- PhotoRefractive Keratectomy (PRK)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of apparent benefits
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic lens alone | Active comparator | Other: Therapeutic lens alone |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental | Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic lens aloneTherapeutic 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. | Other | Therapeutic lens alone |
| 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. | Other | Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
Primary outcome
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Time frame: Day 1
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
5 secondary outcomes
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Time frame: 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)
Time frame: 1 day, 2 days, 3 days, 30 to 45 days
Identical healing of both eyes
Time frame: 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)
Time frame: 30 to 45 days
Rate of corneal haze for each treatment
Time frame: 30 to 45 days
Results and safety
The study was stopped early (reason given: Lack of apparent benefits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX) in people with Myopia and Astigmatism, run by TBF Genie Tissulaire at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of apparent benefits). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.