Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)

Withdrawn

• Conditions: Retinopathy of Prematurity; Diabetic Retinopathy
• Interventions: Device: OCT-A

• Registration Number: NCT03399825
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children

Detailed Description

Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.

Study Timeline

• Study Start: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-16
• Primary Completion: 2018-02-01
• Study Completion: 2018-03-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients (children ≥ 6 <14 years of age) from the Childrens Hospital, University Hospital Bern requiring routine internal medical check-up for the diagnosis of diabetes or children attending routine eye exams at the department of ophthalmology, who are willing to participate in the study, and whos parents are willing to sign informed consent on behalf of their child.
• Patients need to be at least 6 years of age (but younger than 14 years) 6 years of age or younger

Exclusion Criteria

• Patients (children) who are not willing or able to participate, or potential participant's parents who are not willing to sign informed consent on behalf of their child.
• Patients younger than 6 years of age or 14 years or older.
• Patients (children) with epilepsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	OCT-A	Children without eye disease
Retinopathy of prematurity (ROP)	OCT-A	Previously preterm children with a history of ROP
Diabetic retinopathy	OCT-A	Children with diabetes

Primary Outcome Measures

Name	Time	Method
Evaluation of the sensitivity and specificity of OCTA	2 years	The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.