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Completed

NCT Number: NCT03035292

Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

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.

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Key information

Conditions

Childhood Cataract

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Parents / carers with poor conversant English

Treatment and study plan

Red-reflex assessment

Diagnostic Test

The red reflex was examined in the standard manner using direct ophthalmoscope by medical student examiner

Infrared-reflex assessment

Diagnostic Test

The infrared reflex was examined using a modified smart phone camera by a medical student examiner

Primary outcomes

  1. Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard

    Time frame: 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

  2. Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing

    Time frame: 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 outcomes

  1. Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity

    Time frame: 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.

  2. Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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