Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 10:45 AM
Study NCT ID:
NCT05083650
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-18', 'releaseDate': '2024-01-22'}], 'estimatedResultsFirstSubmitDate': '2024-01-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'We never let the patient know the performed surgery'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Large MHs (diameter \\> 550 μm)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of macular hole clousure measured with OCT', 'timeFrame': '6 months', 'description': 'Closure of the macular hole by optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Best-corrected visual acuity measured with Snellen Chart', 'timeFrame': '6 months', 'description': 'Improvement of 2 lines in best-corrected visual acuity'}, {'measure': 'Superficial and deep retinal capillary plexus density with OCT-A', 'timeFrame': '6 months', 'description': 'Presence of capillary plexus in macular hole area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Holes']}, 'descriptionModule': {'briefSummary': 'Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter \\> 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.', 'detailedDescription': 'Interventional study in large macular holes (diameter \\> 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not myopic patients (\\<6 Dioptre or \\<26 mm)\n* Large macular hole \\>550 μm\n* \\> 6 months symptoms\n* Signing informed consent\n\nExclusion Criteria:\n\n* Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)\n* Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)\n* Patients with ocular surgery'}, 'identificationModule': {'nctId': 'NCT05083650', 'briefTitle': 'Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis', 'orgStudyIdInfo': {'id': 'MAM CONDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amniotic membrane without internal limiting membrane peeling', 'description': 'The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade.', 'interventionNames': ['Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amniotic membrane with internal limiting membrane peeling', 'description': 'The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade.', 'interventionNames': ['Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling']}], 'interventions': [{'name': 'Macular hole closure with amniotic membrane with/without internal limiting membrane peeling', 'type': 'PROCEDURE', 'description': 'Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade', 'armGroupLabels': ['Amniotic membrane with internal limiting membrane peeling', 'Amniotic membrane without internal limiting membrane peeling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Jose Luis Rodriguez Loaiza, MD', 'role': 'CONTACT', 'email': 'jose.rodriguez@institutodeoftalmologia.org', 'phone': '+52 5554123012'}], 'facility': 'Instituto de Oftalmologia Conde de Valenciana', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Zita Chao Loyo, MD', 'role': 'CONTACT', 'email': 'investigacionretinaconval@gmail.com', 'phone': '+52 33994182'}], 'overallOfficials': [{'name': 'Daniel Rios Esquer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}, {'name': 'Ishtar A Astorga Carballo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}, {'name': 'Jose L Rodriguez Loaiza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}, {'name': 'Zita Chao Loyo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}, {'name': 'Felipe Esparza Correa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Subdirector', 'investigatorFullName': 'Jose Luis Rodriguez Loaiza', 'investigatorAffiliation': 'Instituto de Oftalmología Fundación Conde de Valenciana'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-01-22', 'type': 'RELEASE'}, {'date': '2024-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jose Luis Rodriguez Loaiza, Medical Subdirector, Instituto de Oftalmología Fundación Conde de Valenciana'}}}}