Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
Study NCT ID:
NCT03902795
Status:
COMPLETED
Last Update Posted:
2019-04-04
First Post:
2019-04-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The best-corrected visual acuity (BCVA)', 'timeFrame': '1 to 6 months', 'description': 'Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable.'}, {'measure': 'Amsler test', 'timeFrame': '1 to 6 months', 'description': 'The standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.'}, {'measure': 'M-charts', 'timeFrame': '1 to 6 months', 'description': 'The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.'}, {'measure': 'Central retinal thickness', 'timeFrame': '1 to 6 months', 'description': 'Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.'}, {'measure': 'Microperimetry', 'timeFrame': '1 to 6 months', 'description': 'Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhegmatogenous retinal detachment', 'Vitrectomy', 'Metamorphopsia', 'M-charts', 'Microperimetry'], 'conditions': ['Retinal Detachment', 'Vitrectomy']}, 'referencesModule': {'references': [{'pmid': '31126280', 'type': 'DERIVED', 'citation': 'Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.'}]}, 'descriptionModule': {'briefSummary': 'To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.', 'detailedDescription': 'Background:\n\nTo examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.\n\nMethods:\n\nThe study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 62 eyes that underwent successful vitrectomy with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.\n\nExclusion Criteria:\n\n* history of uveitis,\n* diabetic retinopathy,\n* previous vitreoretinal surgery,\n* glaucoma or eye trauma,\n* retinal detachment combined with macular hole or proliferative vitreoretinopathy'}, 'identificationModule': {'nctId': 'NCT03902795', 'briefTitle': 'Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade', 'orgStudyIdInfo': {'id': '0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group of 62 eyes', 'description': 'Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade', 'interventionNames': ['Diagnostic Test: Microperimetry', 'Diagnostic Test: M-charts']}], 'interventions': [{'name': 'Microperimetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.', 'armGroupLabels': ['Group of 62 eyes']}, {'name': 'M-charts', 'type': 'DIAGNOSTIC_TEST', 'description': 'The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.', 'armGroupLabels': ['Group of 62 eyes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-001', 'city': 'Lublin', 'country': 'Poland', 'facility': 'General Department of Ophthalmology in Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All data will be available in brief.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}