Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-23 @ 7:30 PM
Study NCT ID:
NCT02655432
Status:
WITHDRAWN
Last Update Posted:
2016-12-02
First Post:
2016-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D012175', 'term': 'Retinoblastoma'}, {'id': 'D014141', 'term': 'Trachoma'}, {'id': 'D014985', 'term': 'Xerophthalmia'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D012178', 'term': 'Retinopathy of Prematurity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'waiting for ethic board approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population', 'timeFrame': '7 days', 'description': 'The epidemiology of vision problems will be evaluated in a sample of haitian children. The ophthalmologic exam will be considered abnormal if it denotes a significant ophthalmologic pathology. A significant ophthalmologic pathology is defined as a significant refractive error, a significant strabismus or a significant media opacity according to the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) Guidelines for automated preschool vision screening. An ophthalmologic pathology is also considered significant in cases of severe ophthalmologic pathologies (xerophthalmia, trachoma, cataract \\>1mm, glaucoma, retinopathy of prematurity, retinoblastoma).'}], 'secondaryOutcomes': [{'measure': 'Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote significant ophthalmologic pathologies according to the 2013 AAPOS guidelines in an haitian pediatric population', 'timeFrame': '7 days', 'description': 'Sensitivity, specificity, positive predictive value and negative predictive value of the abnormal automated vision screening with the photoscreener in comparison of the abnormal screening of the ophthalmologic exam using the criteria of the AAPOS guidelines (gold standard). A significant ophthalmologic pathology is defined as a significant refractive error, a significant strabismus or a significant media opacity according to the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS). The results of the test, being normal vs abnormal, will be compared.'}, {'measure': 'Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote severe ophthalmologic pathologies that are not described in the 2013 AAPOS guidelines in an haitian pediatric population', 'timeFrame': '7 days', 'description': 'Sensitivity, specificity, positive predictive value and negative predictive value of the abnormal automated vision screening with the photoscreener in comparison of the abnormal screening of the ophthalmologic exam for all other severe ophthalmologic pathologies not described in the AAPOS guidelines (gold standard). An ophthalmologic pathology is also considered significant in cases of severe ophthalmologic pathologies (xerophthalmia, trachoma, cataract \\>1mm, glaucoma, retinopathy of prematurity, retinoblastoma). The results of the test, being normal vs abnormal, will be compared.'}, {'measure': 'Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population', 'timeFrame': '7 days', 'description': 'Sensitivity, specificity of the refractive errors measured with the photoscreener compared to the refractive errors measured by the cyclopleged optometric exam (gold standard). The values of the refraction, in dioptries, will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Amblyopia', 'Myopia', 'Hyperopia', 'Astigmatism', 'Cataract', 'Retinoblastoma', 'Trachoma', 'Xerophthalmia', 'Glaucoma', 'Retinopathy of Prematurity']}, 'referencesModule': {'references': [{'pmid': '18772673', 'type': 'BACKGROUND', 'citation': 'Maida JM, Mathers K, Alley CL. Pediatric ophthalmology in the developing world. Curr Opin Ophthalmol. 2008 Sep;19(5):403-8. doi: 10.1097/ICU.0b013e328309f180.'}, {'pmid': '18235892', 'type': 'BACKGROUND', 'citation': 'Resnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210.'}, {'pmid': '17700230', 'type': 'BACKGROUND', 'citation': 'Braverman R. Diagnosis and treatment of refractive errors in the pediatric population. Curr Opin Ophthalmol. 2007 Sep;18(5):379-83. doi: 10.1097/ICU.0b013e328244dfed.'}, {'pmid': '20645997', 'type': 'BACKGROUND', 'citation': "Mathers M, Keyes M, Wright M. A review of the evidence on the effectiveness of children's vision screening. Child Care Health Dev. 2010 Nov;36(6):756-80. doi: 10.1111/j.1365-2214.2010.01109.x."}, {'pmid': '15326895', 'type': 'BACKGROUND', 'citation': 'Krumholtz I. Results from a pediatric vision screening and its ability to predict academic performance. Optometry. 2000 Jul;71(7):426-30.'}, {'pmid': '12461713', 'type': 'BACKGROUND', 'citation': 'Atkinson J, Anker S, Nardini M, Braddick O, Hughes C, Rae S, Wattam-Bell J, Atkinson S. Infant vision screening predicts failures on motor and cognitive tests up to school age. Strabismus. 2002 Sep;10(3):187-98. doi: 10.1076/stra.10.3.187.8125.'}, {'pmid': '15665167', 'type': 'BACKGROUND', 'citation': 'Williams WR, Latif AH, Hannington L, Watkins DR. Hyperopia and educational attainment in a primary school cohort. Arch Dis Child. 2005 Feb;90(2):150-3. doi: 10.1136/adc.2003.046755.'}, {'pmid': '18268218', 'type': 'BACKGROUND', 'citation': "Roch-Levecq AC, Brody BL, Thomas RG, Brown SI. Ametropia, preschoolers' cognitive abilities, and effects of spectacle correction. Arch Ophthalmol. 2008 Feb;126(2):252-8; quiz 161. doi: 10.1001/archophthalmol.2007.36."}, {'pmid': '8574881', 'type': 'BACKGROUND', 'citation': 'Lennerstrand G, Jakobsson P, Kvarnstrom G. Screening for ocular dysfunction in children: approaching a common program. Acta Ophthalmol Scand Suppl. 1995;(214):26-38; discussion 39-40. doi: 10.1111/j.1600-0420.1995.tb00585.x.'}, {'pmid': '9512837', 'type': 'BACKGROUND', 'citation': 'Weinstock VM, Weinstock DJ, Kraft SP. Screening for childhood strabismus by primary care physicians. Can Fam Physician. 1998 Feb;44:337-43.'}, {'pmid': '11922382', 'type': 'BACKGROUND', 'citation': 'Williams C, Harrad RA, Harvey I, Sparrow JM; ALSPAC Study Team. Screening for amblyopia in preschool children: results of a population-based, randomised controlled trial. ALSPAC Study Team. Avon Longitudinal Study of Pregnancy and Childhood. Ophthalmic Epidemiol. 2001 Dec;8(5):279-95. doi: 10.1080/09286586.2001.11644257.'}, {'pmid': '12089090', 'type': 'BACKGROUND', 'citation': 'Williams C, Northstone K, Harrad RA, Sparrow JM, Harvey I; ALSPAC Study Team. Amblyopia treatment outcomes after screening before or at age 3 years: follow up from randomised trial. BMJ. 2002 Jun 29;324(7353):1549. doi: 10.1136/bmj.324.7353.1549.'}, {'pmid': '8475239', 'type': 'BACKGROUND', 'citation': 'Fathy VC, Elton PJ. Orthoptic screening for three- and four-year-olds. Public Health. 1993 Jan;107(1):19-23. doi: 10.1016/s0033-3506(05)80488-3. No abstract available.'}, {'pmid': '8776448', 'type': 'BACKGROUND', 'citation': 'Atkinson J, Braddick O, Robier B, Anker S, Ehrlich D, King J, Watson P, Moore A. Two infant vision screening programmes: prediction and prevention of strabismus and amblyopia from photo- and videorefractive screening. Eye (Lond). 1996;10 ( Pt 2):189-98. doi: 10.1038/eye.1996.46.'}, {'pmid': '17299337', 'type': 'BACKGROUND', 'citation': 'Atkinson J, Braddick O, Nardini M, Anker S. Infant hyperopia: detection, distribution, changes and correlates-outcomes from the cambridge infant screening programs. 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The effectiveness of vision screening by school nurses in secondary school. Arch Dis Child. 1994 Jan;70(1):14-8. doi: 10.1136/adc.70.1.14.'}, {'pmid': '8979754', 'type': 'BACKGROUND', 'citation': 'Cummings GE. Vision screening in junior schools. Public Health. 1996 Nov;110(6):369-72. doi: 10.1016/s0033-3506(96)80010-2.'}, {'pmid': '12881342', 'type': 'BACKGROUND', 'citation': 'Williams C, Northstone K, Harrad RA, Sparrow JM, Harvey I; ALSPAC Study Team. Amblyopia treatment outcomes after preschool screening v school entry screening: observational data from a prospective cohort study. Br J Ophthalmol. 2003 Aug;87(8):988-93. doi: 10.1136/bjo.87.8.988.'}, {'pmid': '9483159', 'type': 'BACKGROUND', 'citation': 'Snowdon SK, Stewart-Brown SL. Preschool vision screening. Health Technol Assess. 1997;1(8):i-iv, 1-83.'}, {'pmid': '10085631', 'type': 'BACKGROUND', 'citation': 'Shamanna BR, Dandona L, Rao GN. Economic burden of blindness in India. Indian J Ophthalmol. 1998 Sep;46(3):169-72.'}, {'pmid': '24560253', 'type': 'BACKGROUND', 'citation': 'Latorre-Arteaga S, Gil-Gonzalez D, Enciso O, Phelan A, Garcia-Munoz A, Kohler J. Reducing visual deficits caused by refractive errors in school and preschool children: results of a pilot school program in the Andean region of Apurimac, Peru. Glob Health Action. 2014 Feb 13;7:22656. doi: 10.3402/gha.v7.22656. eCollection 2014.'}, {'pmid': '25489200', 'type': 'BACKGROUND', 'citation': 'Kedir J, Girma A. Prevalence of refractive error and visual impairment among rural school-age children of Goro District, Gurage Zone, Ethiopia. Ethiop J Health Sci. 2014 Oct;24(4):353-8. doi: 10.4314/ejhs.v24i4.11.'}, {'pmid': '961794', 'type': 'BACKGROUND', 'citation': 'Sommer A, Toureau S, Cornet P, Midy C, Pettiss ST. Xerophthalmia and anterior segment blindness. 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Epub 2014 Jul 8.'}, {'pmid': '24698615', 'type': 'BACKGROUND', 'citation': 'Silbert DI, Matta NS. Performance of the Spot vision screener for the detection of amblyopia risk factors in children. J AAPOS. 2014 Apr;18(2):169-72. doi: 10.1016/j.jaapos.2013.11.019.'}, {'pmid': '24369683', 'type': 'BACKGROUND', 'citation': 'Arnold RW, Armitage MD. Performance of four new photoscreeners on pediatric patients with high risk amblyopia. J Pediatr Ophthalmol Strabismus. 2014 Jan-Feb;51(1):46-52. doi: 10.3928/01913913-20131223-02. Epub 2014 Jan 3.'}, {'pmid': '22398336', 'type': 'BACKGROUND', 'citation': 'Sharma A, Congdon N, Patel M, Gilbert C. School-based approaches to the correction of refractive error in children. Surv Ophthalmol. 2012 May-Jun;57(3):272-83. doi: 10.1016/j.survophthal.2011.11.002. Epub 2012 Mar 6.'}, {'pmid': '23360915', 'type': 'BACKGROUND', 'citation': 'Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. Epub 2013 Jan 27.'}, {'pmid': '21282267', 'type': 'BACKGROUND', 'citation': 'US Preventive Services Task Force. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. Epub 2011 Jan 31.'}, {'pmid': '11875154', 'type': 'BACKGROUND', 'citation': "Committee on Practice and Ambulatory Medicine and Section on Ophthalmology; American Academy of Pediatrics. Use of photoscreening for children's vision screening. Pediatrics. 2002 Mar;109(3):524-5. doi: 10.1542/peds.109.3.524."}, {'pmid': '17983349', 'type': 'BACKGROUND', 'citation': 'Arnold RW, Clausen M, Ryan H, Leman RE, Armitage D. Predictive value of inexpensive digital eye and vision photoscreening: "PPV of ABCD". Binocul Vis Strabismus Q. 2007;22(3):148-52.'}]}, 'descriptionModule': {'briefSummary': 'Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener. The photoscreener results will be compared to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Secondarily, this study will gather epidemiological information on vision problems in the haitian children population.', 'detailedDescription': 'Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener before and after cycloplegia. The photoscreener results will be compared to the complete ophthalmologic evaluation. The ophthalmologic evaluation includes visual acuity, ocular alignment, slit lamp evaluation, cycloplegic refraction and dilated fundus evaluation. First of all, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Second of all, this study will gather epidemiological information on vision problems in the haitian children population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Haitian children aged 3-6 years of age in Limbé, plaine du Nord and Port-au-Prince', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Haitian children aged 3-6 years of age\n* Signed consent form from a legal guardian\n\nExclusion Criteria:\n\n* Previous vision problem diagnostic\n* Unsigned consent form'}, 'identificationModule': {'nctId': 'NCT02655432', 'acronym': 'POPH', 'briefTitle': 'Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': "Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti", 'orgStudyIdInfo': {'id': '20160130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spot photoscreener', 'description': "Automated vision screener: Spot Vision Screener VS 100, Welch-Allyn. This photoscreener is a portable device, using an infrared light. It is built to detect amblyogenic risk factors. First of all, the spot photoscreener produces a sounds which attracts the child's attention and helps him shift his gaze towards the device, held at 1 meter in front him. The spot then evaluates for refractive errors, anisocoria, strabismus, ptosis and media opacity. The ophthalmologic evaluation consists of the measure of the visual acuity, ocular alignment, anterior and posterior segment. The patient will be cyclopleged with cycloplegic drops and will be refracted to obtain a cyclopleged refraction. This will determine his refractive error.", 'interventionNames': ['Device: Spot photoscreener', 'Procedure: Ophthalmologic evaluation', 'Procedure: Cyclopleged refraction']}], 'interventions': [{'name': 'Spot photoscreener', 'type': 'DEVICE', 'description': 'Screening of vision problem through an automated device', 'armGroupLabels': ['Spot photoscreener']}, {'name': 'Ophthalmologic evaluation', 'type': 'PROCEDURE', 'description': 'Screening of vision problem through an ophthalmologic evaluation', 'armGroupLabels': ['Spot photoscreener']}, {'name': 'Cyclopleged refraction', 'type': 'PROCEDURE', 'description': 'Screening of refractive problems through a cyclopleged optometric refraction', 'armGroupLabels': ['Spot photoscreener']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lenbe', 'country': 'Haiti', 'facility': 'École Adventiste de Limbé', 'geoPoint': {'lat': 19.70603, 'lon': -72.40336}}, {'city': 'Pétionville', 'country': 'Haiti', 'facility': 'ClinicA', 'geoPoint': {'lat': 18.5125, 'lon': -72.28528}}, {'city': 'Plaine du Nord', 'country': 'Haiti', 'facility': 'École Saint-Dominique de Plaine du nord', 'geoPoint': {'lat': 19.67707, 'lon': -72.26969}}], 'overallOfficials': [{'name': 'Antoine Sylvestre-Bouchard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}, {'name': 'Patrick Hamel, MD, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Université de Montréal'}, {'name': 'Christelle Doyon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital chef of the ophthalmology department, CHU Sainte-Justine', 'investigatorFullName': 'Patrick Hamel', 'investigatorAffiliation': 'Université de Montréal'}}}}