Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT06702020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VIS Opti-K Vision Improvement for Presbyopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected distance and near visual acuities', 'timeFrame': 'Up to 24 months post-treatment', 'description': 'Uncorrected distance and near visual acuities are measured using ETDRS or similar charts.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Presbyopia Correction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.viscorrect.com', 'label': 'VIS, Inc website'}]}, 'descriptionModule': {'briefSummary': 'The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.', 'detailedDescription': 'The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients had documented presbyopia and a need for near vision improvement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale or male Any race 40 years of age or older Presbyopia\n\nExclusion Criteria:\n\nNone\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06702020', 'acronym': 'VIS Opti-K 002', 'briefTitle': 'VIS Opti-K Vision Improvement for Presbyopes', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIS, Inc.'}, 'officialTitle': 'VIS Opti-K Vision Improvement for Presbyopes', 'orgStudyIdInfo': {'id': 'VIS Opti-K-Presbyopia #002'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael J Berry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VIS, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIS, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}