Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

Completed

• Conditions: Childhood Cataract

• Registration Number: NCT03035292
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

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.

There 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.

Eligible 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.

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Study Start: 2017-02-01
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Results First Submitted: 2018-07-11
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• All children between 1 month and 5 years of age attending paediatric ophthalmology clinic

Exclusion Criteria

• Parents / carers with poor conversant English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard	1 day	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
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity	1 day	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.
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity	1 day	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.

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom