Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02328157
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2014-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}, {'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2014-12-13', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of IOL axis rotation from the end of surgery', 'timeFrame': 'Six months after the inplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract', 'Epiretinal Membrane', 'Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': 'Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism.\n\nSymptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preoperative corneal cylinder of more than 0.75 diopter\n* Symptomatic idiopathic epiretinal membrane\n* Symptomatic cataract\n\nExclusion Criteria:\n\n* Severe media opacity other cataract\n* Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment'}, 'identificationModule': {'nctId': 'NCT02328157', 'briefTitle': 'Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.', 'organization': {'class': 'OTHER', 'fullName': 'Kagawa University'}, 'officialTitle': 'Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.', 'orgStudyIdInfo': {'id': 'H26-061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cataract with ERM and astigmatism', 'description': 'Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.', 'interventionNames': ['Device: Vitrectomy with cataract surgery and toric IOL', 'Device: Vitrectomy with cataract surgery and common IOL']}], 'interventions': [{'name': 'Vitrectomy with cataract surgery and toric IOL', 'type': 'DEVICE', 'armGroupLabels': ['Cataract with ERM and astigmatism']}, {'name': 'Vitrectomy with cataract surgery and common IOL', 'type': 'DEVICE', 'armGroupLabels': ['Cataract with ERM and astigmatism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '761-0793', 'city': 'Hiragi', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa University Faculty of Medicine', 'geoPoint': {'lat': 34.2706, 'lon': 134.13074}}], 'overallOfficials': [{'name': 'AKITAKA TSUJIKAWA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kagawa Univerisity Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kagawa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman', 'investigatorFullName': 'Akitaka Tsujikawa', 'investigatorAffiliation': 'Kagawa University'}}}}