Congenital CataractDIvONCT05282147
Digital Imaging Versus Ophthalmoscopy
A study testing Neocam in people with Congenital Cataract, run by Cambridge University Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- Neocam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All newborn babies having the newborn physical examination
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Cataract
- Being tested
- Neocam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeocamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Babies undergoing newborn eye screening | Other | Babies having newborn eye screening with the intervention (Digital Imaging) technique in addition to the standard ophthalmoscopic technique. Receives: Device: Neocam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Usability feedback
Qualitative usability feedback and test preference using screener questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Louise Allen, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Louise Allen, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282147
- Sponsor's protocol ID
- CCTU0276
- Acronym
- DIvO
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allen L, Bain C, Rose L, Bond S, Rahi J. Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital imaging? The Digital Imaging versus Ophthalmoscopy (DIvO) study. NIHR Open Res. 2026 May 22;3:25. doi: 10.3310/nihropenres.13370.2. eCollection 2023.
PubMed 42299340
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05282147
- Acronym / sponsor ID
- DIvO / CCTU0276
- Conditions
- Congenital Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140,000 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies undergoing newborn eye screening | Other | Device: NeocamBabies having newborn eye screening with the intervention (Digital Imaging) technique in addition to the standard ophthalmoscopic technique. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborn babies having the newborn physical examination
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeocamScreening 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. | Device | Babies undergoing newborn eye screening |
Primary outcome
Sensitivity of the screening evaluation of the Neocam (intervention) test
Time frame: 2 years
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.
Specificity of the screening evaluation of the Neocam (intervention) test
Time frame: 2 years
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.
Sensitivity of the screening evaluation of the standard test
Time frame: 2 years
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.
Specificity of the screening evaluation of the standard test
Time frame: 2 years
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.
1 secondary outcome
Usability feedback
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 42299340Allen L, Bain C, Rose L, Bond S, Rahi J. Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital imaging? The Digital Imaging versus Ophthalmoscopy (DIvO) study. NIHR Open Res. 2026 May 22;3:25. doi: 10.3310/nihropenres.13370.2. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Allen principal investigator
Cambridge University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Neocam in people with Congenital Cataract, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Allen (07941666981, info@divostudy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the screening evaluation of the Neocam (intervention) test (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.