Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 3:28 AM
Study NCT ID:
NCT04297969
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperopia Detection GCK With Glow Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence', 'timeFrame': '1 week', 'description': 'presence of refractive risk factors (anisometropia \\>1.50D, hyperopia \\> 3.5D, Astigmatism \\>1.50D, myopia more than 3D'}], 'secondaryOutcomes': [{'measure': 'Amblyopia', 'timeFrame': '1 week', 'description': 'Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amblyopia Bilateral', 'Hyperopia of Both Eyes', 'Astigmatism Bilateral', 'Accommodation Disorder']}, 'referencesModule': {'references': [{'pmid': '31539614', 'type': 'BACKGROUND', 'citation': 'Racano E, Alessi S, Pertile R. Comparison of 2Win and plusoptiX A12R refractometers with Retinomax handheld autorefractor keratometer. J AAPOS. 2019 Oct;23(5):276.e1-276.e5. doi: 10.1016/j.jaapos.2019.05.017. Epub 2019 Sep 17.'}, {'pmid': '31077668', 'type': 'BACKGROUND', 'citation': 'Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.'}, {'pmid': '29305313', 'type': 'BACKGROUND', 'citation': 'Peterseim MMW, Rhodes RS, Patel RN, Wilson ME, Edmondson LE, Logan SA, Cheeseman EW, Shortridge E, Trivedi RH. Effectiveness of the GoCheck Kids Vision Screener in Detecting Amblyopia Risk Factors. Am J Ophthalmol. 2018 Mar;187:87-91. doi: 10.1016/j.ajo.2017.12.020. Epub 2018 Jan 2.'}, {'pmid': '30197499', 'type': 'BACKGROUND', 'citation': "Arnold RW, O'Neil JW, Cooper KL, Silbert DI, Donahue SP. Evaluation of a smartphone photoscreening app to detect refractive amblyopia risk factors in children aged 1-6 years. Clin Ophthalmol. 2018 Aug 23;12:1533-1537. doi: 10.2147/OPTH.S171935. eCollection 2018."}, {'pmid': '30160295', 'type': 'BACKGROUND', 'citation': 'Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29.'}, {'pmid': '32982148', 'type': 'BACKGROUND', 'citation': 'Levitt AH, Martin SJ, Arnold RW. Performance of Glow Fixation GoCheck Kids and 2WIN Photoscreeners and Retinomax to Uncover Hyperopia. Clin Ophthalmol. 2020 Aug 10;14:2237-2244. doi: 10.2147/OPTH.S256991. eCollection 2020.'}, {'pmid': '33505178', 'type': 'DERIVED', 'citation': 'Arnold RW, Beveridge JS, Martin SJ, Beveridge NR, Metzger EJ, Smith KA. Grading Sphero-Cylinder Spectacle Similarity. Clin Optom (Auckl). 2021 Jan 20;13:23-32. doi: 10.2147/OPTO.S289770. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': '"GoCheck Kids" has added to its iPhone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. In pediatric eye patients, the "GCK" with glow box is compared to cycloplegic refraction as well as School Bus Accommodation-relaxing skiascopy, "2WIN" photoscreener and "Retinomax."', 'detailedDescription': 'Patients undergoing comprehensive pediatric eye exam were screened with "GoCheck Kids" iPhone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as "Adaptica 2WIN" photoscreener and "Retinomax" auto refraction all without drops before cycloplegia examination.\n\nReason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted.\n\nRefractive amblyopia risk factors utilizing "AAPOS 2003" and "AAPOS 2013" uniform guidelines were used to validate each screening method.\n\nPatients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a range of refractive errors including high hyperopia and astigmatism in a pediatric ophthalmology referral practice.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having comprehensive pediatric eye examination\n\nExclusion Criteria:\n\n* Patients with only one eye'}, 'identificationModule': {'nctId': 'NCT04297969', 'briefTitle': 'Hyperopia Detection GCK With Glow Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Alaska Blind Child Discovery'}, 'officialTitle': 'Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device', 'orgStudyIdInfo': {'id': 'ABCD GCK Glow'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GCK Glow fixation', 'description': 'Patients screened with GoCheck Kids flash concentrated iPhone 7+', 'interventionNames': ['Diagnostic Test: objective pediatric vision screen "GCK glow fixation"']}], 'interventions': [{'name': 'objective pediatric vision screen "GCK glow fixation"', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['objective pediatric vision screening GCK glow fixation'], 'description': '2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device', 'armGroupLabels': ['GCK Glow fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Children's EYE & Strabismus", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}]}, 'ipdSharingStatementModule': {'url': 'http://www.abcd-vision.org/references/index.html', 'infoTypes': ['CSR'], 'timeFrame': '1 month from now', 'ipdSharing': 'YES', 'description': 'de-identified data via website', 'accessCriteria': 'Study website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaska Blind Child Discovery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}