N/A
N=110
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Childhood Cataract
Bottom Line
View on ClinicalTrials.gov: NCT03035292 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard — 17; 54; 32; 7 eyes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Red-reflex assessment (Diagnostic_test); Infrared-reflex assessment (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard |
17; 54; 32; 7; 24; 86 | — |
| PRIMARY Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing |
71; 100; 63; 100 | <0.05 sig |
| SECONDARY Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity |
2; 5; 14; 0; 15; 49 | — |
| SECONDARY Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity |
69; 100; 72; 32 | <0.05 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All children between 1 month and 5 years of age attending paediatric ophthalmology clinic
Exclusion Criteria
- Parents / carers with poor conversant English
Data sourced from ClinicalTrials.gov (NCT03035292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.