Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-08 @ 10:44 AM
Study NCT ID:
NCT03035292
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| REC17/EE/0010 | OTHER | IRAS | View |