Choroidal Reflectance Camera for the Detection of Congenital Cataracts
Study Details
Study Description
Brief Summary
Sensitivity and specificity of current screening methods for congenital cataracts in neonates 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. The investigator has developed a new digital technique to improve the accuracy of screening for congenital cataract and this study will compare this new test with the current test performed.
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Detailed Description
All babies born in the United Kingdom undergo eye screening at birth and 6-8 weeks to enable the early diagnosis and management of congenital 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.
The neonatal congenital cataract screening tests are performed by a range of healthcare professionals including nurses, midwives and doctors.
The investigators have developed a new digital camera imaging system based on a modified mobile phone which improves the detection of choroidal reflectance, improving the pick up rate of cataract and other congenital eye malformations and allowing documentation of the examination and telemedicine of the digital image. The investigators predict that this will facilitate screening and improve the early detection and management of congenital cataract worldwide.
Study Design
Outcome Measures
Primary Outcome Measures
- Test of diagnostic sensitivity [8 months]
Comparison of the sensitivity (true positive rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination
- Test of diagnostic specificity [8 months]
Comparison of the specificity (true negative rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination
Secondary Outcome Measures
- Comparison of ease of use in differing ethnic groups [8 months]
Comparison of difficulty of assessment using a questionnaire completed by the examiner with reference to ethnic group
Eligibility Criteria
Criteria
Inclusion Criteria:
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All newborns having NIPE screening.
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All children under 5 years of age attending paediatric ophthalmology clinic
Exclusion Criteria:
- Parents / carers with poor conversant English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addenbrooke's Hospital | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
Sponsors and Collaborators
- Cambridge University Hospitals NHS Foundation Trust
Investigators
- Principal Investigator: Louise E Allen, MBBS MD, Cambridge University Hospitals NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 159569
- REC17/EE/0010