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

Investigation of Vascular Pathology in Eye Diseases Using Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Retinopathy; Retinopathy of Prematurity
• Intervention / Treatment: Device: OCT-A

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with a history of clinically diagnosed retinal diseases and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; Children without eye disease	Device: OCT-A; optical coherence tomography angiography Imaging with optical coherence tomography angiography
Retinopathy of prematurity (ROP); Previously preterm children with a history of ROP	Device: OCT-A; optical coherence tomography angiography Imaging with optical coherence tomography angiography
Diabetic retinopathy; Children with diabetes	Device: OCT-A; optical coherence tomography angiography Imaging with optical coherence tomography angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the sensitivity and specificity of OCTA	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.	2 years

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Infant, Newborn, Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Infant, Premature, Diseases; Retinal Diseases; Diabetic Retinopathy; Retinopathy of Prematurity
• Other Study ID Numbers: OCTA children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No