Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT05247658
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Lack of apparent benefits', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)', 'timeFrame': 'Day 1', 'description': 'Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes'}], 'secondaryOutcomes': [{'measure': 'Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)', 'timeFrame': '2 days, 3 days, 30 to 45 days', 'description': 'Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes'}, {'measure': 'Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)', 'timeFrame': '1 day, 2 days, 3 days, 30 to 45 days', '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'}, {'measure': 'Identical healing of both eyes', 'timeFrame': '2 or 3 days, 30 to 45 days', 'description': 'Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size'}, {'measure': 'Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)', 'timeFrame': '30 to 45 days', 'description': 'Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes'}, {'measure': 'Rate of corneal haze for each treatment', 'timeFrame': '30 to 45 days', 'description': "Evaluation of presence of corneal haze through the Hanna's grading scale from grade 0: no haze to grade 4: very severe haze"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PhotoRefractive Keratectomy (PRK)'], 'conditions': ['Myopia', 'Astigmatism', 'Hypermetropia']}, 'descriptionModule': {'briefSummary': 'The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.', 'detailedDescription': '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.\n\nPreliminary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 to 80 years.\n* 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.\n* Patient understanding french language.\n* Patient who received the study information and provided written consent to participation in the study.\n* Patient who is a member or a beneficiary of a national health insurance plan.\n\nExclusion Criteria:\n\n* Pregnant woman.\n* Patient with a contraindication to PRK.\n* Diabetic patient.\n* Patient allergic to Oxybuprocaine and / or Tetracaine eye drops, to local anesthetics or to fluorescein.\n* Monophthalmic patient.\n* Person deprived of liberty by a judicial or administrative decision.\n* Adult subjected to a legal protection measure or unable to express his / her consent.'}, 'identificationModule': {'nctId': 'NCT05247658', 'briefTitle': 'Use of a Disk of Amniotic Membrane (Visio-AMTRIX) in Postoperative Care After PKR', 'organization': {'class': 'INDUSTRY', 'fullName': 'TBF Genie Tissulaire'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'AMTRIX-PKR-TBF'}, 'secondaryIdInfos': [{'id': '2021-A01933-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic lens alone', 'interventionNames': ['Other: Therapeutic lens alone']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic lens + amniotic membrane (Visio-AMTRIX)', 'interventionNames': ['Other: Therapeutic lens + amniotic membrane (Visio-AMTRIX)']}], 'interventions': [{'name': 'Therapeutic lens alone', 'type': 'OTHER', '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.", 'armGroupLabels': ['Therapeutic lens alone']}, {'name': 'Therapeutic lens + amniotic membrane (Visio-AMTRIX)', 'type': 'OTHER', '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.", 'armGroupLabels': ['Therapeutic lens + amniotic membrane (Visio-AMTRIX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Clinique Vision Laser des Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '13006', 'city': 'Marseille', 'country': 'France', 'facility': "Centre Monticelli-Paradis d'Ophtalmologie", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'CHU de Saint-Etienne Hôpital Nord', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TBF Genie Tissulaire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}