Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT03021512
Status:
UNKNOWN
Last Update Posted:
2017-01-16
First Post:
2017-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Capacity (VC)', 'timeFrame': '1 year following surgery', 'description': 'Assessment of Visual capacity (VC)'}], 'secondaryOutcomes': [{'measure': 'Distant Visual Capacity (DVC)', 'timeFrame': '1 year following surgery', 'description': 'Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation'}, {'measure': 'Intermediate Visual Capacity (IVC)', 'timeFrame': '1 year following surgery', 'description': 'Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge'}, {'measure': 'Near Visual Capacity (NVC)', 'timeFrame': '1 year follwoing surgery', 'description': 'Visual Capacity for activities that require near vision (NVC). NVC score will be measured by the performance score in the following ADLs: a) cellular phone directory entry search, b) reading of message in a cellular phone, c) reading a medical prescription, d) reading a public phonebook'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Grade 1 Cataract Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation\n\nExclusion Criteria:\n\n* Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder'}, 'identificationModule': {'nctId': 'NCT03021512', 'briefTitle': 'Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses', 'orgStudyIdInfo': {'id': '299/13-1-2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (BFG)', 'description': '(Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention).', 'interventionNames': ['Procedure: Phaco with Restor']}, {'label': 'Group 2 (TFG)', 'description': '(Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention).', 'interventionNames': ['Procedure: Phaco with Panoptix']}], 'interventions': [{'name': 'Phaco with Restor', 'type': 'PROCEDURE', 'description': 'Phacoemulsification with bilateral bifocal intraocular lenses implantation', 'armGroupLabels': ['Group 1 (BFG)']}, {'name': 'Phaco with Panoptix', 'type': 'PROCEDURE', 'description': 'Phacoemulsification with bilateral trifocal intraocular lenses implantation', 'armGroupLabels': ['Group 2 (TFG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'CONTACT', 'email': 'labiris@usa.net', 'phone': '00302551030990'}], 'facility': 'Democritus University of Thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'centralContacts': [{'name': 'Dimitrios Aggelonias', 'role': 'CONTACT', 'email': 'dimagelonias@yahoo.com', 'phone': '00302551039891'}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}