Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-06 @ 6:23 PM
Study NCT ID:
NCT03314766
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-12', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TCNVA', 'timeFrame': '12 months', 'description': 'Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.'}], 'secondaryOutcomes': [{'measure': 'Overall Satisfaction', 'timeFrame': '12 months', 'description': 'Overall satisfaction with postoperative vision at least 12 months post-operatively, with an outcome of objective of 85% or more being either very satisfied or satisfied.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Presbyopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.', 'detailedDescription': 'This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.\n\nThe purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for this study will be recruited from the clinical sites that participated in the prior open-label, multicenter study (protocol ACU-P14-029). Anticipated study sample size of no more than 80 patients should effectively demonstrate the long-term clinical acceptability of the IC-8 IOL implanted in aphakic patients.\n\nPatients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.\n2. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1\\. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -"}, 'identificationModule': {'nctId': 'NCT03314766', 'briefTitle': 'Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'AcuFocus, Inc.'}, 'officialTitle': 'Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens', 'orgStudyIdInfo': {'id': 'IC-8 203-LTCA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IC-8 IOL', 'description': 'Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029', 'interventionNames': ['Device: IC-8 IOL']}], 'interventions': [{'name': 'IC-8 IOL', 'type': 'DEVICE', 'description': 'Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation', 'armGroupLabels': ['IC-8 IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48683', 'city': 'Ahaus', 'country': 'Germany', 'facility': 'Augen Zentrum Nordwest', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Universitats-Augenklinik, Department of Ophthalmology', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '36061', 'city': 'Bassano del Grappa', 'country': 'Italy', 'facility': 'San Bassano Hospital', 'geoPoint': {'lat': 45.76656, 'lon': 11.72739}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'Centro Microchirurgia Ambulatoriale', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '5527', 'city': 'Haugesund', 'country': 'Norway', 'facility': 'Ifocus Øyeklinikk', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '04120', 'city': 'Almería', 'country': 'Spain', 'facility': 'QVision (Unidad Oftalmología Hospital Virgen del Mar)', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia, Servicio de Oftalmología', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}], 'overallOfficials': [{'name': 'Nicholas Tarantino, OD', 'role': 'STUDY_DIRECTOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AcuFocus, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}