Digital Imaging Versus Ophthalmoscopy

NCT05282147 | Unknown

• 1 other identifier: CCTU0276
• Study Type: interventional
• Target: 140,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cataract (cloudiness of the lens) is the major cause of avoidable child blindness in the world and affects 1 in 3000 UK infants. Screening may fail to detect a cataract in an affected child (false-negative) or mistakenly suggest there is a cataract (false positive) triggering urgent unnecessary referral. Screening is currently undertaken using an ophthalmoscope into the eye to assess the reddish reflected light (red-reflex). This study aims to test if screening using a new hand-held digital imaging device (Neocam) is more accurate than the ophthalmoscope for newborn eye screening.

Conditions

Congenital Cataract

Outcome Measures

Primary Outcomes (4)

• Sensitivity of the screening evaluation of the Neocam (intervention) test

  The proportion of patients correctly identified as having cataract by a positive Neocam screening test result. Where a higher value indicates better sensitivity of the screening test for presence of cataract.

  2 years

• Specificity of the screening evaluation of the Neocam (intervention) test

  The proportion of patients correctly identified as not having cataract by a negative Neocam screening test result. Where a higher value indicates better specificity of the screening test for absence of cataract.

  2 years

• Sensitivity of the screening evaluation of the standard test

  The proportion of patients correctly identified as having cataract by a positive standard screening test result. Where a higher value indicates better sensitivity of the screening test for presence of cataract.

  2 years

• Specificity of the screening evaluation of the standard test

  The proportion of patients correctly identified as not having a cataract by a negative standard screening result. Where a higher value indicates better specificity of the screening test for absence of cataract.

  2 years

Secondary Outcomes (1)

• Usability feedback

  2 years

Study Arms (1)

Babies undergoing newborn eye screening

OTHER

Babies having newborn eye screening with the intervention (Digital Imaging) technique in addition to the standard ophthalmoscopic technique.

Device: Neocam

Interventions

Neocam DEVICE

Screening within 72 hours of birth will be completed using the digital imaging device Neocam which painlessly images the eye's reflection firstly to infrared light and then to a brief green light flash.

Babies undergoing newborn eye screening

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All newborn babies having the newborn physical examination

You may not qualify if:

• None

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Officials

• Louise Allen

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Allen

CONTACT

07941666981; info@divostudy.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 7, 2022

Record last verified: 2022-03