Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 10:08 AM
Study NCT ID:
NCT01933750
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near Visual Acuity', 'timeFrame': '12 Months', 'description': 'Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months'}], 'secondaryOutcomes': [{'measure': 'Uncorrected Near Visual Acuity', 'timeFrame': '12 Months', 'description': 'The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months'}, {'measure': 'Presence of Significant Safety Events', 'timeFrame': '24 months', 'description': 'Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Presbyopia', 'Reading Glasses', 'Near Vision'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45 or older at commencement of study\n* Best Corrected Distance Visual Acuity of .80 (20/25) or better\n* Patients must be alert, mentally competent, and able to comply with clinical study requirements\n\nExclusion Criteria:\n\n* Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery\n* Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.\n* Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases'}, 'identificationModule': {'nctId': 'NCT01933750', 'briefTitle': 'Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients', 'nctIdAliases': ['NCT01910207'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Refocus Ocular Europe, B.V.'}, 'officialTitle': 'A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients', 'orgStudyIdInfo': {'id': 'EU-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Randomized/Control', 'description': '7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21'}, {'type': 'EXPERIMENTAL', 'label': 'Non-Randomized/Treatment', 'description': 'Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device', 'interventionNames': ['Device: PresVIEW Device Implantation']}], 'interventions': [{'name': 'PresVIEW Device Implantation', 'type': 'DEVICE', 'armGroupLabels': ['Non-Randomized/Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Midland Eye', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Refocus Ocular Europe, B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}