N/A
Completed N=110
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Childhood Cataract
Source: ClinicalTrials.gov NCT03035292 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard — 17; 54; 32; 7 eyes
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.
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 |
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. Informational only — not medical advice.