Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-08 @ 10:44 AM
Study NCT ID:
NCT03035292
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r&denquiries@addenbrookes.nhs.uk', 'phone': '01223 217418', 'title': 'Dr Stephen Kelleher, Director of R&D', 'organization': 'Cambridge University Hospitals NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Children Recruited to Diagnostic Comparison Study', 'description': '110 children recruited to diagnostic accuracy comparison trial from clinic. These patients had initial red-reflex and infra-red reflex assessment using an imaging device performed by a medical student prior to gold standard examination by a paediatric ophthalmologist', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eyes Tested in the Diagnostic Comparison Study', 'description': 'Eyes of children having red-reflex and infrared reflex tests'}], 'classes': [{'title': 'Red-reflex test true positive', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Red-reflex test true negative', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Red-reflex test false positive', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Red-reflex test false negative', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Infrared-reflex test true positive', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Infrared-reflex test true negative', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Infrared-reflex test false positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Infrared-reflex test false negative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'True positives: the number of eyes with cataract correctly identified True negatives: the number of eyes without cataract correctly identified False positives: the number of eyes without cataracts incorrectly identified as having cataract False negatives positives: the number of eyes with cataract incorrectly identified as not having cataract', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'populationDescription': '110 children were eligible for the study, each had their right eye assessed by a medical student using 1) red-reflex assessment 2) Infrared-reflex assessment. Findings were compared to a gold standard examination by an ophthalmologist.'}, {'type': 'PRIMARY', 'title': 'Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eyes Tested in the Diagnostic Comparison Study', 'description': 'Results of red-reflex, infra-red reflex findings compared to gold standard'}], 'classes': [{'title': 'Sensitivity of red-reflex', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '89'}]}]}, {'title': 'Sensitivity of infrared-reflex', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '100'}]}]}, {'title': 'Specificity of red-reflex', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '73'}]}]}, {'title': 'Specificity of infrared-reflex', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'pValueComment': 'This value of \\<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.', 'groupDescription': 'Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Sensitivity (percentage of eyes with cataract correctly identified) and specificity (percentage of eyes without cataract correctly identified) of red-reflex and infrared-reflex testing in percentage terms with 95% Confidence Intervals. Sensitivity and specificity are recorded as a percentage, with 100% indicating best accuracy.', 'unitOfMeasure': 'percentage of eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': '110 eyes (of 110 children) recruited to the study'}, {'type': 'SECONDARY', 'title': 'Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eyes Tested in the Diagnostic Comparison Study', 'description': 'Eyes of children undergoing red-reflex and infrared-reflex assessment'}], 'classes': [{'title': "Red-reflex true positives in BAME children's eyes", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex true negatives in BAME children's eyes", 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex false positives in BAME children's eyes", 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex false negatives in BAME children's eyes", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex true positives in white children's eyes", 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex true negatives in white children's eyes", 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex false positives in white children's eyes", 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': "Red-reflex false negatives in white children's eyes", 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex true positives in BAME children's eyes", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex true negatives in BAME children's eyes", 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex false positives in BAME children's eyes", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex false negatives in BAME childrens' eyes", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex true postives in white children's eyes", 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex true negatives in white children's eyes", 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex false positives in white children's eyes", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Infrared-reflex false negatives in white children's eyes", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 day', 'description': "True positives: the number of eyes with cataract correctly identified in caucasian children's eyes and in BAME children's eyes. True negatives: the number of eyes without cataract correctly identified in caucasian children's eyes and in BAME children's eyes. False positives: the number of eyes without cataract incorrectly identified as having cataract in caucasian children's eyes and in BAME children's eyes. False negatives: the number of eyes with cataract incorrectly identified as not having cataract in caucasian children's eyes and in BAME children's eyes.", 'calculatePct': False, 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'of 110 eligible children, 89 (81%) were caucasian, 21(19%) were of Black, Asian or minority ethnicity (BAME)'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eyes Tested in the Diagnostic Comparison Study', 'description': '110 right eyes of 110 children of diverse ethnicity tested with the two fundus reflex techniques. Eyes first underwent red-reflex assessment (Intervention 1) and then infrared-reflex assessment (intervention 2) performed by a medical student prior to gold standard examination by a paediatric ophthalmologist'}], 'classes': [{'title': 'Sensitivity of red-reflex in caucasian eyes', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '88'}]}]}, {'title': 'Sensitivity of red-reflex in BAME eyes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '100'}]}]}, {'title': 'Specificity of red-reflex in caucasian eyes', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '82'}]}]}, {'title': 'Specificity of red-reflex in BAME eyes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '53'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'pValueComment': 'The calculated p value was \\<0.05. A priori threshold for statistical significance is p=0.05', 'groupDescription': 'Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Sensitivity (percentage of eyes with cataract correctly identified) and specificity (percentage of eyes without cataract correctly identified) of red-reflex and infrared-reflex testing in percentage terms with 95% Confidence Intervals. Sensitivity and specificity are recorded as a percentage, with 100% indicating best accuracy.', 'unitOfMeasure': 'percentage of eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': '89 (81%) were the eyes of caucasian children, 21(19%) were the eyes of Black, Asian or minority ethnicity (BAME) children'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children Recruited to Diagnostic Comparison Study', 'description': 'Right eyes of children recruited to the study who underwent the following sequential examinations at the time of their clinic appointment: 1) red-reflex assessment by a medical student using direct ophthalmoscope 2) infrared-reflex assessment by the same medical student using the choroidal reflectance imaging device and 3) gold standard ophthalmic examination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '110', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '110', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'Diagnostic accuracy comparison trial: children from 1 month to 5 years of age (with no previous history of ophthalmic surgery) attending a specialist paediatric out-patient clinic were enrolled into the study over a 3 month period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Children Recruited to Diagnostic Comparison Study', 'description': 'The data from right eyes of 110 children recruited to diagnostic accuracy comparison trial from clinic. These patients had initial red-reflex assessment (Intervention 1) and then infrared-reflex assessment (intervention 2) performed by a medical student prior to gold standard examination by a paediatric ophthalmologist'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '3.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ethnicity', 'categories': [{'title': 'white', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': 'black, asian, minority ethnic', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Evaluator assessment of reflex', 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Children having red-reflex, infrared-reflex and gold standard examination. Data for the right eye only was analysed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-17', 'size': 1160010, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-08T07:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2017-01-24', 'resultsFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-30', 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard', 'timeFrame': '1 day', 'description': 'True positives: the number of eyes with cataract correctly identified True negatives: the number of eyes without cataract correctly identified False positives: the number of eyes without cataracts incorrectly identified as having cataract False negatives positives: the number of eyes with cataract incorrectly identified as not having cataract'}, {'measure': 'Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing', 'timeFrame': '1 day', 'description': 'Sensitivity (percentage of eyes with cataract correctly identified) and specificity (percentage of eyes without cataract correctly identified) of red-reflex and infrared-reflex testing in percentage terms with 95% Confidence Intervals. Sensitivity and specificity are recorded as a percentage, with 100% indicating best accuracy.'}], 'secondaryOutcomes': [{'measure': 'Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity', 'timeFrame': '1 day', 'description': "True positives: the number of eyes with cataract correctly identified in caucasian children's eyes and in BAME children's eyes. True negatives: the number of eyes without cataract correctly identified in caucasian children's eyes and in BAME children's eyes. False positives: the number of eyes without cataract incorrectly identified as having cataract in caucasian children's eyes and in BAME children's eyes. False negatives: the number of eyes with cataract incorrectly identified as not having cataract in caucasian children's eyes and in BAME children's eyes."}, {'measure': 'Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity', 'timeFrame': '1 day', 'description': 'Sensitivity (percentage of eyes with cataract correctly identified) and specificity (percentage of eyes without cataract correctly identified) of red-reflex and infrared-reflex testing in percentage terms with 95% Confidence Intervals. Sensitivity and specificity are recorded as a percentage, with 100% indicating best accuracy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cataract']}, 'referencesModule': {'references': [{'pmid': '9933197', 'type': 'BACKGROUND', 'citation': 'Rahi JS, Dezateux C. National cross sectional study of detection of congenital and infantile cataract in the United Kingdom: role of childhood screening and surveillance. The British Congenital Cataract Interest Group. BMJ. 1999 Feb 6;318(7180):362-5. doi: 10.1136/bmj.318.7180.362.'}, {'pmid': '32546747', 'type': 'BACKGROUND', 'citation': 'Mndeme FG, Mmbaga BT, Kim MJ, Sinke L, Allen L, Mgaya E, Bastawrous A, MacLeod D, Burton MJ, Gilbert C, Bowman R. Red reflex examination in reproductive and child health clinics for early detection of paediatric cataract and ocular media disorders: cross-sectional diagnostic accuracy and feasibility studies from Kilimanjaro, Tanzania. Eye (Lond). 2021 May;35(5):1347-1353. doi: 10.1038/s41433-020-1019-5. Epub 2020 Jun 16.'}, {'pmid': '31267092', 'type': 'RESULT', 'citation': 'Duret A, Humphries R, Ramanujam S, Te Water Naude A, Reid C, Allen LE. The infrared reflex: a potential new method for congenital cataract screening. Eye (Lond). 2019 Dec;33(12):1865-1870. doi: 10.1038/s41433-019-0509-9. Epub 2019 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Sensitivity and specificity of current screening methods for childhood cataracts is poor. This results in delayed diagnosis and management which can decrease the visual prognosis following cataract surgery. It also results in many false positives with resultant unnecessary healthcare costs in specialist paediatric ophthalmology services. This study compares the accuracy of cataract screening using infrared light compared to white light in a population of children attending eye clinic.', 'detailedDescription': 'All babies born in the United Kingdom (UK) undergo eye screening to enable the early diagnosis and management of childhood cataract, a treatable but potentially blinding condition affecting 1 in 2000 newborns. The current technique involves the assessment of the "red-reflex" - the orange/red glow in the pupil seen during ophthalmoscopy (or flash photography) due to reflectance of light from the back of the eye. In reality, testing can be technically difficult because the pupil constricts to light during the examination and, particularly in babies of Asian and Afro-Caribbean ancestry, the red-reflex can be dim due to the effect of ocular pigmentation. As a result less than 50% of congenital cataracts are currently identified up by screening. Early visual experience is required for good visual development and a delay in the surgical management of cataracts results in sub-optimal visual development and visual impairment.\n\nThere are theoretical advantages to using Infrared (IR) light rather than white light to assess choroidal reflectance, including avoidance of pupil constriction. The study aims to determine if the assessment of the IR-reflex, using a prototype device, rather than the red-reflex, using a direct ophthalmoscope, improves screening accuracy in the detection of ocular media opacities in a pathology enriched childhood cohort.\n\nEligible children attending an eye clinic will be screened for cataract by a medical student (masked to the pathology) using the existing standard direct ophthalmoscope technique for red-reflex assessment and IR-reflex assessment using the prototype imaging device. A gold standard examination by an ophthalmologist will follow the screening examinations. Sensitivity and specificity of each screening technique will be calculated and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants and children from 1 month to 5 years of age attending a specialist paediatric ophthalmology clinic with or without known cataracts.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children between 1 month and 5 years of age attending paediatric ophthalmology clinic\n\nExclusion Criteria:\n\n* Parents / carers with poor conversant English'}, 'identificationModule': {'nctId': 'NCT03035292', 'briefTitle': 'Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Proof of Concept Trial of a Novel Imaging System to Assess and Document Choroidal Reflectance in Children for the Detection of Cataract and Media Opacities.', 'orgStudyIdInfo': {'id': '159569'}, 'secondaryIdInfos': [{'id': 'REC17/EE/0010', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children attending eye clinic', 'description': 'Children 1 month to 5 years of age attending paediatric ophthalmology clinic with and without cataracts. Children who had previously had intra-ocular surgery were excluded.\n\nOne eye of each child was assessed by an inexperienced screener (medical student) by red-reflex assessment using direct ophthalmoscope and infrared-reflex using a new device (CatCam). CatCam is a modified smart phone camera which images the reflection of co-axial infrared light from the ocular fundus. A cataract appears as a black silhouette on the white infrared-reflex imaged by the camera.\n\nSensitivity and specificity for red-reflex and infrared-reflex assessment compared to gold standard dilated ophthalmic examination by a specialised were compared.', 'interventionNames': ['Diagnostic Test: Red-reflex assessment', 'Diagnostic Test: Infrared-reflex assessment']}], 'interventions': [{'name': 'Red-reflex assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'The red reflex was examined in the standard manner using direct ophthalmoscope by medical student examiner', 'armGroupLabels': ['Children attending eye clinic']}, {'name': 'Infrared-reflex assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'The infrared reflex was examined using a modified smart phone camera by a medical student examiner', 'armGroupLabels': ['Children attending eye clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Louise E Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Paediatric Ophthalmologist', 'investigatorFullName': 'Dr Louise Allen', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}