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

Study Overview
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Brief Summary
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Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children

Detailed Description
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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.

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

Conditions
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Retinopathy of Prematurity, Diabetic Retinopathy

Intervention / Treatment
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* Device: OCT-A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>Children without eye disease | Device: OCT-A<br>* optical coherence tomography angiography Imaging with optical coherence tomography angiography<br>|
| Retinopathy of prematurity (ROP)<br>Previously preterm children with a history of ROP | Device: OCT-A<br>* optical coherence tomography angiography Imaging with optical coherence tomography angiography<br>|
| Diabetic retinopathy<br>Children with diabetes | Device: OCT-A<br>* optical coherence tomography angiography Imaging with optical coherence tomography angiography<br>|

What is the study measuring?
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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 |