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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03399825

Acronym

OCTAC

Enrollment

Registered

2018-01-16

Start date

2018-01-31

Completion date

2018-03-01

Last updated

2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity, Diabetic Retinopathy

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.

Interventions

DEVICEOCT-A

optical coherence tomography angiography Imaging with optical coherence tomography angiography

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026