Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04693702
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2020-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Vision Improvement in Patients With Retinal Disorders
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2020-12-31', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CDVA', 'timeFrame': '12 months', 'description': 'Best spectacle-corrected distance visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related macular degeneration', 'Diabetic macular edema'], 'conditions': ['Age-related Macular Degeneration', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.', 'detailedDescription': 'The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with vision impairment due to retinal disorders involving central vision loss', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- Female or male\n2. \\- Any race\n3. \\- Patient is at least 50 years old\n4. \\- Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes\n5. \\- Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract\n6. \\- Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)\n7. \\- Patient CDVA records are available at baseline and at 1m or longer post-Tx times\n\nExclusion Criteria:\n\n1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04693702', 'briefTitle': 'Observational Study of Vision Improvement in Patients With Retinal Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optimal Acuity Corporation'}, 'officialTitle': 'Observational Study of Vision Improvement in Patients With Retinal Disorders', 'orgStudyIdInfo': {'id': 'Retro2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age-related Macular Degeneration', 'interventionNames': ['Device: Corneal treatment by a low vision aid device']}, {'label': 'Diabetic Macular Edema', 'interventionNames': ['Device: Corneal treatment by a low vision aid device']}], 'interventions': [{'name': 'Corneal treatment by a low vision aid device', 'type': 'DEVICE', 'description': 'Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.', 'armGroupLabels': ['Age-related Macular Degeneration', 'Diabetic Macular Edema']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5R 1A9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bochner Eye Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Michael J Berry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optimal Acuity Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Acuity Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}