Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 5:41 AM
Study NCT ID:
NCT04045704
Status:
WITHDRAWN
Last Update Posted:
2021-10-04
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cataract Surgery on Advanced Age Related Macular Degeneration Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No study coordinator available. No patient recruitment possible.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life style Questionnaire to determine change in visual function.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Our primary outcome will be a life style questionnaire (qualitative) to determine the change in visual function from baseline to after surgery.\n\nThis questionnaire includes 25 close-ended questions that are graded on a 5 point grading scale from 1 (great difficulty due to vision) and 5 (no problem due to vision). The questions can also be graded as not applicable to an individuals life, or 0 being something there are no longer possible to do, due to vision.\n\nThe 25 close-ended questions are divided into 4 sub-scales:\n\n1. Distance Vision, Mobility, and Lighting (Q: 1-12)\n2. Adjustment (Q:13-16)\n3. Reading and Fine Work (Q: 17-21)\n4. Activities of Daily Living (Q: 22-25)\n\nA total score can range from a 125 indicating best visual function to 0 indicating complete loss of visual function.'}], 'secondaryOutcomes': [{'measure': 'Snellens Chart to determine change in visual acuity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Quantitative measure of a patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.'}, {'measure': 'Auto Refractive to determine change in visual acuity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'An auto-refractor is a computerized machine to measure patients visual acuity. Change from baseline visual acuity to after surgery on both eyes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Macular Degeneration Advanced']}, 'descriptionModule': {'briefSummary': 'The degree at which cataract surgery improves visual function in patients with advanced age-related macular degeneration (Advanced AMD) has been an on-going topic of discussion. Our objective in this study is to determine if patients with Advanced AMD and concurrent cataracts will experience greater improvement in their quality of life from having cataract surgery on one or both eyes. The findings from this project will provide evidence for clinical decision making on whether performing bilateral cataract surgery on Advanced AMD patients is cost-effective and worth the second surgical intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients above the age of fifty with both Advanced AMD and Cataracts bilaterally from the Okanagan Valley will be selected for this study.\n\nPatients who chose to have bilateral cataract surgery, were able to understand the research parameters, and had no other severe eye disease that may distort the studies results.\n\nPatients will be selected for the study according to the National Eye Institute definition of Advanced AMD.\n\n"Advanced AMD (AREDS category 4) is characterized by one or more of the following (in the absence of other causes) in one eye:\n\nGeographic atrophy of the RPE involving the foveal center.\n\nNeovascular maculopathy that includes the following:\n\n* Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch\'s membrane\n* Serous and/or hemorrhagic detachment of the neurosensory retina or RPE\n* Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)\n* Subretinal and sub-RPE fibrovascular proliferation\n* Disciform scar (subretinal fibrosis)"\n\nExclusion Criteria:\n\n* Severe intraoperative or postoperative complications such as retinal detachments, and capsule ruptures\n* Inability to complete the required testing (auto-refractive and visual acuity)\n* Inability to attend appointments\n* Inability to complete the questionnaire with Co-I assistance\n* Severe eye disease that may distort the studies results such as but not limited to Epithelial Basement Membrane Dystrophy (EBMD) and retinal detachments.'}, 'identificationModule': {'nctId': 'NCT04045704', 'briefTitle': 'Cataract Surgery on Advanced Age Related Macular Degeneration Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Effects of Unilateral and Bilateral Cataract Extraction on Visual Function of Advanced Age-Related Macular Degeneration Patients.', 'orgStudyIdInfo': {'id': 'H19-00830'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Patients with bilateral Advanced Age-related macular degeneration and concurrent cataracts will be receiving bilateral cataract surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Jeffrey Chambers', 'investigatorAffiliation': 'University of British Columbia'}}}}