Childhood CataractNCT03035292
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
An observational study of Childhood Cataract, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Cataract
- What is being tested?
- Red-reflex assessment and Infrared-reflex assessment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 1 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants and children from 1 month to 5 years of age attending a specialist paediatric ophthalmology clinic with or without known cataracts.
Who may be able to join
- All children between 1 month and 5 years of age attending paediatric ophthalmology clinic
Who cannot join
- Parents / carers with poor conversant English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
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.
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.
Read the 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.
- Conditions
- Childhood Cataract
- Being tested
- Red-reflex assessment, Infrared-reflex assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red-reflex assessmentDiagnostic test
The red reflex was examined in the standard manner using direct ophthalmoscope by medical student examiner
Infrared-reflex assessmentDiagnostic test
The infrared reflex was examined using a modified smart phone camera by a medical student examiner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Red-reflex assessment; Diagnostic Test: Infrared-reflex assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity
True positives: the number of eyes with cataract correctly identified in caucasian children's eyes and in BAME children's eyes. True negatives: the number of eyes without cataract correctly identified in caucasian children's eyes and in BAME children's eyes. False positives: the number of eyes without cataract incorrectly identified as having cataract in caucasian children's eyes and in BAME children's eyes. False negatives: the number of eyes with cataract incorrectly identified as not having cataract in caucasian children's eyes and in BAME children's eyes.
Measured: 1 day
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
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 E Allen, MD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035292
- Sponsor's protocol ID
- 159569
- Other IDs
- REC17/EE/0010
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2017
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9933197Mndeme 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.
PubMed 32546747Duret 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.
PubMed 31267092
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03035292
- Acronym / sponsor ID
- 159569
- Conditions
- Childhood Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children attending eye clinic | – | Diagnostic Test: Red-reflex assessment, Diagnostic Test: Infrared-reflex assessmentChildren 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. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants and children from 1 month to 5 years of age attending a specialist paediatric ophthalmology clinic with or without known cataracts.
Key inclusion criteria (1 listed)
- All children between 1 month and 5 years of age attending paediatric ophthalmology clinic
Key exclusion criteria (1 listed)
- Parents / carers with poor conversant English
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 |
|---|---|---|
| Red-reflex assessmentThe red reflex was examined in the standard manner using direct ophthalmoscope by medical student examiner | Diagnostic test | Children attending eye clinic |
| Infrared-reflex assessmentThe infrared reflex was examined using a modified smart phone camera by a medical student examiner | Diagnostic test | Children attending eye clinic |
Primary outcome
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard
Time frame: 1 day
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
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing
Time frame: 1 day
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.
2 secondary outcomes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity
Time frame: 1 day
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9933197Rahi 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.
- Background: PubMed 32546747Mndeme 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.
- Results publication: PubMed 31267092Duret 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.
- Individual participant dataSharing planned: No
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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 E Allen, MD principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cataract, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard (time frame: 1 day). The study lists 2 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 NCT03035292, which also lists 3 linked publications.
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 Nov 2023.