Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02111356
Status:
UNKNOWN
Last Update Posted:
2014-04-11
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine Functions of Pinhole Glasses on the Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance and near visual acuity(DVA, NVA)', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Check distance(4m) and near(40cm) visual acuity using Snellen chart, Visual Acuity chart 2000, respectively.\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)'}], 'secondaryOutcomes': [{'measure': 'Pupil size', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Check the pupil size using WASCA Analyzer(Carl Zeiss Meditec, Germany)'}, {'measure': 'Depth of focus', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Check with 4m Snellen chart.\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)'}, {'measure': 'Accomodation', 'timeFrame': 'Change from baseline at 1 week', 'description': "check by Donder's push-up method. The subject was instructed to view the target letter (20/20 reduced Snellen number), which initially was positioned at approximately 40 cm. The target then was moved progressively closer to the patient's eye at approximately 5 cm per second until the subject noticed the target starting to blur.\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)"}, {'measure': 'Visual field', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Humphrey Visual Field Analyzer (Carl Zeiss Meditec, Inc., Dublin, CA, USA) using a 30-2 Swedish Interactive Threshold Algorithm\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)'}, {'measure': 'Contrast sensitivity', 'timeFrame': 'Change from baseline at 1 week', 'description': 'CSV-1000E Contrast Testing Instrument (VectorVision, Dayton, OH, USA) at 2.5m distance under the standard brightness (85 cd/m2)\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)'}, {'measure': 'Stereopsis', 'timeFrame': 'Change from baseline at 1 week', 'description': 'Randot Stereotest (Stereo Optical Co, Chicago, Illinois, USA)\n\nAt 1 week, cheked with wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vision, Ocular']}, 'referencesModule': {'references': [{'pmid': '25118263', 'type': 'DERIVED', 'citation': 'Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014 Aug 12;55(10):6679-85. doi: 10.1167/iovs.14-14801.'}]}, 'descriptionModule': {'briefSummary': 'Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : between 20 and 50 years old\n* Visual acuity : correctable distant and near visual acuity by glasses up to 20/20\n* Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.\n\nExclusion Criteria:\n\n* History of systemic or topical medication that might affect accommodation\n* Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.'}, 'identificationModule': {'nctId': 'NCT02111356', 'acronym': 'PH001', 'briefTitle': 'Determine Functions of Pinhole Glasses on the Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, 'officialTitle': 'Quantative Analysis of Functional Changes by the Pinhole Glasses', 'orgStudyIdInfo': {'id': 'PH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pinhole glasses', 'description': 'All subjects perform ophthalmic examinations before and after the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)', 'interventionNames': ['Device: Phinhole glasses']}], 'interventions': [{'name': 'Phinhole glasses', 'type': 'DEVICE', 'description': 'Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)', 'armGroupLabels': ['Pinhole glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'WonSoo Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology, Chung Ang University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'WonSoo Kim', 'investigatorFullName': 'WonSoo Kim', 'investigatorAffiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}}}}