DIvO

Congenital cataract is the main treatable cause of global childhood blindness. 'Red-reflex' assessment with an ophthalmoscope during the UK Newborn and Infant Physical Examination (NIPE) screening programme enables early detection and timely surgery, preventing permanent visual impairment.

Evidence for red-reflex screening accuracy is lacking but surveys suggest a high false negative and positive rate, particularly in minority ethnic babies. Recently, a digital imaging (DI) device, Neocam has been developed; this is a hand-held digital camera incorporating co-axial LED (Light Emitting Diode).

Because cataract is so rare in babies, we need to compare both screening methods in 140,000 babies. This trial will be conducted at 24 large maternity units across England.

Neocam is camera developed by an NHS children's eye doctor to address the difficulties with the current cataract screening method. Neocam takes a photo using infrared and green light. Photoscreening may make the assessment easier especially in babies of black or Asian ethnicity.

Babies will be having the standard eye screening test before being discharged home and can additionally have photoscreening with the Neocam device as part of this study. Photoscreening is very quick and causes no discomfort, just like the standard eye screening test.

Both the standard and Neocam screening tests are undertaken while the baby is in hospital. Unless either test detects a possible problem, no additional hospital visits are necessary and no further active participation in the study is required.

We aim to determine whether the sensitivity and specificity of newborn eye screening is better using assessment of the Neocam IR-reflex image than the existing assessment, potentially improving the accuracy of the UK NIPE screening programme.