Digital Imaging Versus Ophthalmoscopy (DIvO)

Can the Diagnostic Accuracy of Newborn Eye Screening for Congenital Cataract be Improved With Digital Dual Light Source Imaging? The Digital Imaging vs Ophthalmoscopy (DIvO)Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Cataract
• Intervention / Treatment: Device: Neocam

Detailed Description

Cataract (cloudiness of the lens) is the major cause of avoidable child blindness in the world and affects 1 in 3000 UK infants. Cataracts are present in both eyes in more than half of the babies affected. Surgery is required by 8 weeks of age to prevent permanent visual impairment at this critical time of vision and brain development. All UK babies are examined (screened) for cataract twice within the first 8 weeks of life but late diagnosis continues to be a problem, causing avoidable visual impairment in some affected children.

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, parental anxiety and wasted NHS resources. Screening is currently performed by midwives and doctors shining a bright white light torch (an ophthalmoscope) into the eye to assess the reddish reflected light (red-reflex), similar to "red eye" seen in flash photos. Cataract causes a dark shadow on the red-reflex but the test can be difficult because bright light causes the pupils to constrict and the babies to forcefully shut their eyes. Assessment is particularly difficult in ethnic minority infants since eye pigmentation affects the hue and brightness of the 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. Neocam painlessly images the eye's reflection firstly to infrared light and then to a brief green light flash. Its infrared light causes no pupil constriction or avoidance response and the reflection is bright and consistent regardless of the baby's ethnicity. Its brief green flash and immediate imaging allows a photo of the red-reflex to be captured before the pupil has time to constrict.

To compare the accuracy of both tests, the investigators seek to enrol 140,000 newborn babies in a two year study period. All babies will have both the current ophthalmoscope screening test and additional Neocam imaging. If either test is potentially abnormal, the baby will be referred for specialist examination.

A more accurate screening test could prevent life-long disability and reduce costs to the NHS and society. This study will allow a future estimation of what these savings might be and whether changing to a digital imaging screening service might be justified. The result may have an impact on eye screening world-wide to prevent childhood blindness from cataract.

• Study Type: Interventional
• Enrollment (Anticipated): 140000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise Allen; Phone Number: 07941666981; Email: info@divostudy.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All newborn babies having the newborn physical examination

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Babies undergoing newborn eye screening; Babies having newborn eye screening with the intervention (Digital Imaging) technique in addition to the standard ophthalmoscopic technique.	Device: Neocam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability feedback	Qualitative usability feedback and test preference using screener questionnaire.	2 years

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Louise Allen, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCTU0276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No