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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

Tracking Information
First Submitted Date January 24, 2017
First Posted Date January 30, 2017
Last Update Posted Date June 27, 2017
Actual Study Start Date February 1, 2017
Estimated Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03035292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Choroidal Reflectance Camera for the Detection of Congenital Cataracts
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.
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Congenital Cataract
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 25, 2017)
260
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2017
Estimated Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03035292
Other Study ID Numbers 159569
REC17/EE/0010 ( Other Identifier: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Louise Allen, Cambridge University Hospitals NHS Foundation Trust
Study Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Louise E Allen, MBBS MD Cambridge University Hospitals NHS Trust
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date June 2017