Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01226160
Status:
COMPLETED
Last Update Posted:
2010-10-22
First Post:
2010-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2010-10-21', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Visual acuity assessed 6 weeks following surgery by Snellen charts.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Full Thickness Macular Hole']}, 'descriptionModule': {'briefSummary': 'This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full thickness macular hole\n* \\>16 years old\n\nExclusion Criteria:\n\n* any history of previous intraocular surgery (including cataract surgery)\n* history of ocular trauma\n* history of visual loss greater than 1 year'}, 'identificationModule': {'nctId': 'NCT01226160', 'briefTitle': 'Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole', 'organization': {'class': 'OTHER', 'fullName': 'Moorfields Eye Hospital NHS Foundation Trust'}, 'officialTitle': 'Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole', 'orgStudyIdInfo': {'id': '06/Q0603/100/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face-down posturing group', 'description': 'Postoperative face-down positioning for 10 days after surgery.', 'interventionNames': ['Procedure: Postoperative face-down posturing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-posturing group', 'description': 'avoid a face-up position for 10 days after surgery', 'interventionNames': ['Procedure: Postoperative non-posturing group']}], 'interventions': [{'name': 'Postoperative face-down posturing', 'type': 'PROCEDURE', 'description': 'Postoperative face-down posturing for 10 days after surgery.', 'armGroupLabels': ['Face-down posturing group']}, {'name': 'Postoperative non-posturing group', 'type': 'PROCEDURE', 'description': 'avoid a face-up position only for 10 days after surgery', 'armGroupLabels': ['Non-posturing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1V 2PD', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': "Moorfileld's Eye Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moorfields Eye Hospital NHS Foundation Trust', 'class': 'OTHER'}}}}