Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-27 @ 10:02 AM
Study NCT ID:
NCT02431156
Status:
UNKNOWN
Last Update Posted:
2015-04-30
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision 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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Visual capacity (VC)', 'timeFrame': '1 year following mini-monovision correction surgery', 'description': 'VC will be measured as the sum of DVC, IVC, and NVC'}], 'secondaryOutcomes': [{'measure': 'Visual capacity for activities that require distant vision (DVC)', 'timeFrame': '1 year following mini-monovision correction surgery', 'description': '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': 'Visual capacity for activities that require intermediate vision (IVC)', 'timeFrame': '1 year following mini-monovision correction surgery', 'description': 'IVC 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': 'Visual capacity for activities that require near vision (NVC)', 'timeFrame': '1 year following mini-monovision correction surgery', 'description': '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': True}, 'conditionsModule': {'keywords': ['presbyopia', 'monovision', 'activities of daily living,', 'pseudophakic'], 'conditions': ['Presbyopia']}, 'referencesModule': {'references': [{'pmid': '28116335', 'type': 'DERIVED', 'citation': 'Labiris G, Ntonti P, Patsiamanidi M, Sideroudi H, Georgantzoglou K, Kozobolis VP. Evaluation of activities of daily living following pseudophakic presbyopic correction. Eye Vis (Lond). 2017 Jan 19;4:2. doi: 10.1186/s40662-016-0067-1. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery 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 objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants.', 'detailedDescription': 'Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery 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 objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation\n\nExclusion Criteria:\n\n* Glaucoma\n* Corneal pathology\n* Fundus pathology\n* Severe neurological/mental diseases that interfere with visual acuity'}, 'identificationModule': {'nctId': 'NCT02431156', 'briefTitle': 'Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction With Bilateral Implantation of Aspheric Monofocal Intraocular Lenses', 'orgStudyIdInfo': {'id': 'PseudoPresbADL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'monovision', 'description': 'Presbyopic patients that underwent mini-monovision correction with bilateral implantation of monofocal intraocular lenses. Their visual capacity in ADLs will be assessed.', 'interventionNames': ['Other: Assessment of visual capacity']}], 'interventions': [{'name': 'Assessment of visual capacity', 'type': 'OTHER', 'description': 'Visual capacity (VC) is variable comprised by three sub-variables: a) (DVC) Visual capacity for activities requiring distant vision, b) (IVC) Visual capacity for activities requiring intermediate vision, and c) (NVC) Visual capacity for activities requiring near vision.\n\nVC will be measured in a scale from 1 to 100 as the sum of the DVC, IVC and NVC', 'armGroupLabels': ['monovision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Aggelonias Dimitrios', 'role': 'CONTACT', 'email': 'dimagelonias@yahoo.com', 'phone': '00302551030991'}], 'facility': 'Eye Institute Of thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'centralContacts': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'CONTACT', 'email': 'labiris@usa.net', 'phone': '00302551039891'}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}