Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

NCT03035292 | Completed Results

• 2 other identifiers: 159569REC17/EE/0010
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cataract

Outcome Measures

Primary Outcomes (2)

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

  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

  1 day

• Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing

  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.

  1 day

Secondary Outcomes (2)

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

  1 day

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

  1 day

Study Arms (1)

Children attending eye clinic

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.

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

Interventions

Red-reflex assessment DIAGNOSTIC_TEST

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

Children attending eye clinic

Infrared-reflex assessment DIAGNOSTIC_TEST

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

Children attending eye clinic

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Parents / carers with poor conversant English

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 9933197 BACKGROUND

• 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.

  PMID: 32546747 BACKGROUND

• 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.

  PMID: 31267092 RESULT

Results Point of Contact

• Title: Dr Stephen Kelleher, Director of R&D
• Organization: Cambridge University Hospitals NHS Trust

r&denquiries@addenbrookes.nhs.uk

01223 217418

Study Officials

• Louise E Allen, MD

  Cambridge University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Paediatric Ophthalmologist

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 30, 2017
• Study Start: February 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)