Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 1:22 AM
Study NCT ID:
NCT04116892
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2019-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Large Macular Hole Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2019-09-29', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MH status', 'timeFrame': 'at 3 months after surgery', 'description': 'MH status (open, flat open or closed)'}, {'measure': 'IS/OS line interruption width', 'timeFrame': 'at 3 months after surgery', 'description': 'IS/OS line interruption width were gauged with spectral-domain optical coherence tomography'}, {'measure': 'Change from Baseline IS/OS line interruption width at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'IS/OS line interruption width were gauged with spectral-domain optical coherence tomography'}, {'measure': 'Baseline best-corrected visual acuity', 'timeFrame': 'at 3 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'Change from Baseline best-corrected visual acuity at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'visual function', 'timeFrame': 'at 3 months after surgery', 'description': 'visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)'}, {'measure': 'Change from Baseline visual function at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inverted Internal Limiting Membrane Flap Technique', 'Large Macular Hole', 'Macular hole surgery'], 'conditions': ['Macular Holes']}, 'descriptionModule': {'briefSummary': 'This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.', 'detailedDescription': 'Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.\n\nExclusion Criteria:\n\n* High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, \\>21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.'}, 'identificationModule': {'nctId': 'NCT04116892', 'acronym': 'CAOLMHS', 'briefTitle': 'Comparative Analysis of Large Macular Hole Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries', 'orgStudyIdInfo': {'id': 'IR001094'}, 'secondaryIdInfos': [{'id': '2019-142', 'type': 'OTHER', 'domain': '2nd Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'the peeling group', 'description': 'the internal limiting membrane was discarded', 'interventionNames': ['Procedure: the peeling group']}, {'type': 'EXPERIMENTAL', 'label': 'the Cover group', 'description': 'the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.', 'interventionNames': ['Procedure: the Cover group']}, {'type': 'EXPERIMENTAL', 'label': 'the Fill group', 'description': 'the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.', 'interventionNames': ['Procedure: the Fill group']}], 'interventions': [{'name': 'the Cover group', 'type': 'PROCEDURE', 'description': 'The internal limiting membrane around the MH was left to cover the hole', 'armGroupLabels': ['the Cover group']}, {'name': 'the Fill group', 'type': 'PROCEDURE', 'description': 'The internal limiting membrane around the MH was left to fill the hole', 'armGroupLabels': ['the Fill group']}, {'name': 'the peeling group', 'type': 'PROCEDURE', 'description': 'the internal limiting membrane was discarded', 'armGroupLabels': ['the peeling group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyong Zhang, docter', 'role': 'CONTACT', 'email': 'zhangziyongnet@163.com', 'phone': '13968059392'}], 'facility': 'Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhiyong Zhang, docter', 'role': 'CONTACT', 'email': 'zhangziyongnet@163.com', 'phone': '13968059392'}], 'overallOfficials': [{'name': 'Tao Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}