Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT04875234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-22
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vision Improvement for Legally Blind Dry AMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D001766', 'term': 'Blindness'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best spectacle-corrected distance visual acuity (BCDVA)', 'timeFrame': '12 months post-treatment', 'description': 'BCDVA measured using ETDRS eye charts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMD, vision impairment, blindness'], 'conditions': ['Dry Age-related Macular Degeneration', 'Vision Impairment and Blindness']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.', 'detailedDescription': 'This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with dry age-related macular degeneration an legal blindness in one or both eyes', 'healthyVolunteers': True, 'eligibilityCriteria': 'IInclusion Criteria:\n\n* Male or Female\n* Any race\n* Patient is at least 50 years old.\n* Patient must have dry AMD in the study eye.\n* Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.\n* Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).\n* Patient is not a contact lens wearer.\n* Patient is willing and able to comply with all examinations.\n* Patient must be competent to sign an informed consent form before study entry.\n\nExclusion Criteria:\n\n* Visually significant cataract in the study eye\n* Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye\n* Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye\n* Previous corneal surgery in the study eye\n* Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study'}, 'identificationModule': {'nctId': 'NCT04875234', 'briefTitle': 'Vision Improvement for Legally Blind Dry AMD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optimal Acuity Corporation'}, 'officialTitle': 'Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients', 'orgStudyIdInfo': {'id': 'Retro3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Legally Blind Dry AMD Patients', 'description': 'Legally Blind Dry AMD Patients with either unilateral or bilateral blindness', 'interventionNames': ['Device: Clear-K Low Vision Aid Treatment']}], 'interventions': [{'name': 'Clear-K Low Vision Aid Treatment', 'type': 'DEVICE', 'description': 'A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.', 'armGroupLabels': ['Legally Blind Dry AMD Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael Berry, PhD', 'role': 'CONTACT', 'email': 'mberry177@gmail.com', 'phone': '831-869-1384'}], 'overallOfficials': [{'name': 'Michael Berry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optimal Acuity Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Acuity Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}