Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT06597292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patient IDs will be assigned and used.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Distance Visual Acuity (UDVA)', 'timeFrame': 'Up to 24 months post-treatment', 'description': 'Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.'}, {'measure': 'Uncorrected Near Visual Acuity (UNVA)', 'timeFrame': 'Up to 24 months post-treatment', 'description': 'Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vision improvement'], 'conditions': ['Hyperopia', 'Presbyopia']}, 'descriptionModule': {'briefSummary': 'The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nSubjects who meet all of the following criteria are candidates for this study:\n\n1. Male or Female\n2. Any race\n3. Patient is at least 40 years old.\n4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.\n5. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.\n6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.\n7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.\n8. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \\< 0.70) in eye(s) to be treated.\n9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.\n10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.\n11. Patient is not a contact lens (CL) wearer.\n12. Patient has normal corneal topography.\n13. Patient is willing and able to comply with all examinations.\n14. Patient must be competent to sign an informed consent form before study entry.\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria are to be excluded from this study:\n\n1. Corneal disease or corneal disorder in either eye.\n2. Any active ocular surface disease of any severity.\n3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.\n4. Previous corneal surgery in the eye to be treated.\n5. Conjunctivochalasis\n6. Nystagnus\n7. Diabetes\n8. Pregnancy\n9. 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 that may confound the outcome of the study.\n\nnclusion Criteria: -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06597292', 'acronym': 'Opti-K Pres', 'briefTitle': 'The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIS, Inc.'}, 'officialTitle': 'Vision Improvement for Patients With Presbyopia', 'orgStudyIdInfo': {'id': 'VIS Opti-K-Presbyopia #001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vision improvement', 'interventionNames': ['Device: Vision improvement']}], 'interventions': [{'name': 'Vision improvement', 'type': 'DEVICE', 'description': 'Vision improvement for patients with refractive disorders (hyperopia and presbyopia)', 'armGroupLabels': ['Vision improvement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Michael Berry, PhD', 'role': 'CONTACT', 'email': 'mberry177@gmail.com', 'phone': '831-869-1384'}], 'facility': 'VIS, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': 'L4K 0J4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Arvind Kattar', 'role': 'CONTACT', 'email': 'akattar@clarityeye.ca', 'phone': '416-278-3202'}, {'name': ':Paul Sanghera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clarity Eye Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Michael Berry, PhD', 'role': 'CONTACT', 'email': 'mberry177@gmail.com', 'phone': '8318691384'}, {'name': 'Harry Glen, MD', 'role': 'CONTACT', 'email': 'oceans11@bellsouth.net', 'phone': '561-252-0946'}], 'overallOfficials': [{'name': 'Michael Berry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VIS, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIS, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}