Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05437302
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2022-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Four week', 'description': 'Near and Distance visual acuity are measured in log Mar units.'}, {'measure': 'Visual Functional Quality of life (VFQOL)', 'timeFrame': 'Four weeks', 'description': 'VFQOL is measured by a validated tool VFQOL-25.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'A study is conducted to determine the effectiveness of prism spectacles in improving visual acuity with age related macular degeneration patients and to assess the improvement in quality of life in patients by using prism spectacles.', 'detailedDescription': 'A random sampling technique will be used to allocate patient in interventional and non-interventional group. The diagnosed patients of age-related macular degeneration are assessed for prism spectacles for near vision and prism glasses will be dispensed to the patients. Each subject will be interviewed to fill the Proforma after taking the informed consent. The results of this study will show the effectiveness of prism glasses in patients with age related macular degeneration in their daily routine near work as compared to conventional glasses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having age \\>50 years with age related macular degeneration.\n* Patients of both genders (male and female).\n* Participants who will be willing to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Presence of all ocular disease and systemic ocular pathologies able to impair visual function.\n* Presence of disorders causing choroidal neovascularization other than age related macular degeneration.\n* Patients with mental illness, dementia, and severe physical limitations'}, 'identificationModule': {'nctId': 'NCT05437302', 'briefTitle': 'Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'Ufaisalabad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventional', 'description': 'prism spectacles prescribed', 'interventionNames': ['Device: prism spectacle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non interventional', 'description': 'presbyopia glasses prescribed', 'interventionNames': ['Device: prism spectacle']}], 'interventions': [{'name': 'prism spectacle', 'type': 'DEVICE', 'description': 'a prism is dispensed in prescription glasses', 'armGroupLabels': ['interventional', 'non interventional']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'country': 'Pakistan', 'facility': 'Mehreen', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Ayesha Kiran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Faisalabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'mehreen tanveer', 'investigatorAffiliation': 'University of Faisalabad'}}}}