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
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||260 participants|
|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|
- 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
- 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
- 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
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
|Contact: Louise E Allen, MBBS MD||+441223 email@example.com|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Contact: Humma Shahid, MBBS FRCOPhth Humma.firstname.lastname@example.org|
|Principal Investigator:||Louise E Allen, MBBS MD||Cambridge University Hospitals NHS Trust|