Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT03661593
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2018-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aniseikonia in Epiretinal Membrane Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking done by a third person following computer randomization'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aniseikonia', 'timeFrame': '1 year', 'description': 'Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'Examination of aniseikonia in epiretinal membranes patients before and after surgery', 'detailedDescription': 'Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epiretinal membrane Phakic on both eyes\n\nExclusion Criteria:\n\n* no previous eye surgeries\n* refractive status +/- 2 seq'}, 'identificationModule': {'nctId': 'NCT03661593', 'briefTitle': 'Aniseikonia in Epiretinal Membrane Patients', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Aniseikonia in Epiretinal Membranes', 'orgStudyIdInfo': {'id': 'H-16020057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cataract guideline', 'description': 'In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery', 'interventionNames': ['Other: Cataract guideline']}, {'type': 'NO_INTERVENTION', 'label': 'Standard refraction', 'description': 'The patients gets an IOL ensuring his preoperatively refraction'}], 'interventions': [{'name': 'Cataract guideline', 'type': 'OTHER', 'description': 'The patients gets an IOL according to cataract guideline correcting the ametropia', 'armGroupLabels': ['Cataract guideline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Therese Krarup, MD', 'role': 'CONTACT', 'email': 'theresekrarup@gmail.com', 'phone': '+45 38633963'}], 'facility': 'Eye department, Nordre ringvej 56', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No planing on sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Therese Krarup', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}