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

NCT ID: NCT03399825

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-03-01

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.

Conditions

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Retinopathy of Prematurity Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

Children without eye disease

OCT-A

Intervention Type DEVICE

optical coherence tomography angiography

Imaging with optical coherence tomography angiography

Retinopathy of prematurity (ROP)

Previously preterm children with a history of ROP

OCT-A

Intervention Type DEVICE

optical coherence tomography angiography

Imaging with optical coherence tomography angiography

Diabetic retinopathy

Children with diabetes

OCT-A

Intervention Type DEVICE

optical coherence tomography angiography

Imaging with optical coherence tomography angiography

Interventions

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OCT-A

optical coherence tomography angiography

Imaging with optical coherence tomography angiography

Intervention Type DEVICE

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OCTA children

Identifier Type: -

Identifier Source: org_study_id

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