Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

NHS Foundation Trust

Status: Completed

Conditions: Childhood Cataract

Treatments: Diagnostic Test: Red-reflex assessment; Diagnostic Test: Infrared-reflex assessment

Study type: Observational

Funder types: Other

Identifiers

NCT03035292

159569

REC17/EE/0010 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Parents / carers with poor conversant English

Trial design

110 participants in 1 patient group

Children attending eye clinic

Description:

Children 1 month to 5 years of age attending paediatric ophthalmology clinic with and without cataracts. Children who had previously had intra-ocular surgery were excluded. One eye of each child was assessed by an inexperienced screener (medical student) by red-reflex assessment using direct ophthalmoscope and infrared-reflex using a new device (CatCam). CatCam is a modified smart phone camera which images the reflection of co-axial infrared light from the ocular fundus. A cataract appears as a black silhouette on the white infrared-reflex imaged by the camera. Sensitivity and specificity for red-reflex and infrared-reflex assessment compared to gold standard dilated ophthalmic examination by a specialised were compared.

Treatment:

Diagnostic Test: Red-reflex assessment

Diagnostic Test: Infrared-reflex assessment