Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-07 @ 8:04 PM
Study NCT ID:
NCT03045367
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D019654', 'term': 'Lens Implantation, Intraocular'}, {'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '180 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metamorphopsia', 'timeFrame': 'Change in metamorphopsia from baseline at 180 days.', 'description': 'Change in spatial degree of distortion perception'}, {'measure': 'Visual Acuity', 'timeFrame': 'Change in visual acuity from baseline at 180 days', 'description': 'Change in LogMAR visual acuity'}, {'measure': 'Area of central scotoma', 'timeFrame': 'Change in area of central scotoma from baseline at 180 days', 'description': 'Change in area, in square pixel, of central scotoma'}, {'measure': 'Central fovea thickness', 'timeFrame': 'Change in fovea thickness from baseline at 180 days', 'description': 'Change in fovea thickness in µm at the Sd OCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metamorphopsia', 'Epiretinal membrane', 'Vitrectomy'], 'conditions': ['Epiretinal Membrane', 'Cataract Senile']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient of all gender, with complain of visual impairment and distortion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 55 years\n* visual acuity ≤ 20/40\n* idiopathic epiretinal membrane\n* cataract\n* Amsler test positive for metamorphopsia.\n\nExclusion Criteria:\n\n* previous ocular interventions\n* other ocular diseases.'}, 'identificationModule': {'nctId': 'NCT03045367', 'briefTitle': 'Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery', 'organization': {'class': 'OTHER', 'fullName': "Clinica Oculistica dell'Università di Torino"}, 'officialTitle': 'Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery', 'orgStudyIdInfo': {'id': 'CS/526'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatients', 'description': 'Phacoemulsification, intraocular lens implant, vitrectomy.', 'interventionNames': ['Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.']}], 'interventions': [{'name': 'Phacoemulsification, intraocular lens implant, vitrectomy.', 'type': 'PROCEDURE', 'description': 'Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.', 'armGroupLabels': ['Outpatients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Clinica Oculistica dell'Università di Torino", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Marco DAL VECCHIO, MD', 'investigatorAffiliation': "Clinica Oculistica dell'Università di Torino"}}}}