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Choroidal Reflectance Camera for the Detection of Congenital Cataracts

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ClinicalTrials.gov Identifier: NCT03035292
Recruitment Status : Unknown
Verified June 2017 by Dr Louise Allen, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Louise Allen, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
Sensitivity and specificity of current screening methods for congenital cataracts in neonates 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. The investigator has developed a new digital technique to improve the accuracy of screening for congenital cataract and this study will compare this new test with the current test performed.

Condition or disease
Congenital Cataract

Detailed Description:

All babies born in the United Kingdom undergo eye screening at birth and 6-8 weeks to enable the early diagnosis and management of congenital 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.

The neonatal congenital cataract screening tests are performed by a range of healthcare professionals including nurses, midwives and doctors.

The investigators have developed a new digital camera imaging system based on a modified mobile phone which improves the detection of choroidal reflectance, improving the pick up rate of cataract and other congenital eye malformations and allowing documentation of the examination and telemedicine of the digital image. The investigators predict that this will facilitate screening and improve the early detection and management of congenital cataract worldwide.


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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proof of Concept Trial of a Novel Imaging System to Assess and Document Choroidal Reflectance in Infants for the Detection of Cataract and Media Opacities.
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract




Primary Outcome Measures :
  1. Test of diagnostic sensitivity [ Time Frame: 8 months ]
    Comparison of the sensitivity (true positive rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination

  2. Test of diagnostic specificity [ Time Frame: 8 months ]
    Comparison of the specificity (true negative rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination


Secondary Outcome Measures :
  1. Comparison of ease of use in differing ethnic groups [ Time Frame: 8 months ]
    Comparison of difficulty of assessment using a questionnaire completed by the examiner with reference to ethnic group



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Babies undergoing screening for congenital cataracts as part of the Newborn and Infant Physical examinations (NIPE). Infants and children up to 5 years of age attending a specialist paediatric ophthalmology clinic with or without known cataracts.
Criteria

Inclusion Criteria:

  • All newborns having NIPE screening.
  • All children under 5 years of age attending paediatric ophthalmology clinic

Exclusion Criteria:

  • Parents / carers with poor conversant English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035292


Contacts
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Contact: Louise E Allen, MBBS MD +441223 216700 louise.allen@addenbrookes.nhs.uk

Locations
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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Humma Shahid, MBBS FRCOPhth       Humma.shahid@addenbrookes.nhs.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Louise E Allen, MBBS MD Cambridge University Hospitals NHS Trust

Publications of Results:
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Responsible Party: Dr Louise Allen, Consultant Paediatric Ophthalmologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03035292     History of Changes
Other Study ID Numbers: 159569
REC17/EE/0010 ( Other Identifier: IRAS )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases