Clinical trial NCT03035292: Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cataract
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children from 1 month to 5 years of age attending a specialist paediatric ophthalmology clinic with or without known cataracts.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Parents / carers with poor conversant English

Primary outcomes:
measure: Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard
timeFrame: 1 day
measure: Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing
timeFrame: 1 day
Secondary outcomes:
measure: Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity
timeFrame: 1 day
measure: Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity
timeFrame: 1 day
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Trust
name: Louise E Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahi JS, Dezateux C. National cross sectional study of detection of congenital and infantile cataract in the United Kingdom: role of childhood screening and surveillance. The British Congenital Cataract Interest Group. BMJ. 1999 Feb 6;318(7180):362-5. doi: 10.1136/bmj.318.7180.362.
citation: Mndeme FG, Mmbaga BT, Kim MJ, Sinke L, Allen L, Mgaya E, Bastawrous A, MacLeod D, Burton MJ, Gilbert C, Bowman R. Red reflex examination in reproductive and child health clinics for early detection of paediatric cataract and ocular media disorders: cross-sectional diagnostic accuracy and feasibility studies from Kilimanjaro, Tanzania. Eye (Lond). 2021 May;35(5):1347-1353. doi: 10.1038/s41433-020-1019-5. Epub 2020 Jun 16.
citation: Duret A, Humphries R, Ramanujam S, Te Water Naude A, Reid C, Allen LE. The infrared reflex: a potential new method for congenital cataract screening. Eye (Lond). 2019 Dec;33(12):1865-1870. doi: 10.1038/s41433-019-0509-9. Epub 2019 Jul 2.