Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-23 @ 4:28 AM
Study NCT ID:
NCT00894192
Status:
UNKNOWN
Last Update Posted:
2009-05-06
First Post:
2009-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Evaluation of Visual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-05', 'studyFirstSubmitDate': '2009-05-04', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity, and Contrast Sensitivity', 'timeFrame': 'Once a week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.'], 'conditions': ['Visual Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.', 'detailedDescription': 'The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have normal vision\n* Are far-sighted or near-sighted\n* Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.'}, 'identificationModule': {'nctId': 'NCT00894192', 'briefTitle': 'Comprehensive Evaluation of Visual Function', 'organization': {'class': 'OTHER', 'fullName': 'The Chicago Lighthouse'}, 'officialTitle': 'Comprehensive Evaluation of Visual Function', 'orgStudyIdInfo': {'id': 'OPH-2005-0516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wavefront guided lenses', 'interventionNames': ['Device: Izon Wavefront-guided lenses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional lenses', 'interventionNames': ['Device: Conventional lenses']}], 'interventions': [{'name': 'Izon Wavefront-guided lenses', 'type': 'DEVICE', 'description': 'Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.', 'armGroupLabels': ['Wavefront guided lenses']}, {'name': 'Conventional lenses', 'type': 'DEVICE', 'description': 'We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.', 'armGroupLabels': ['Conventional lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samar Suleman, BA', 'role': 'CONTACT', 'email': 'samar.suleman@chicagolighthouse.org', 'phone': '312-447-3234'}, {'name': 'Janet Szlyk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Chicago Lighthouse', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Samar Suleman, BA', 'role': 'CONTACT', 'email': 'samar.suleman@chicagolighthouse.org', 'phone': '312-447-3234'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Chicago Lighthouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ophthonix Inc', 'class': 'INDUSTRY'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Janet Szlyk, PhD', 'oldOrganization': 'The Chicago Lighthouse'}}}}