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

Diabetic Retinopathy Clinical Trial

— OCTAC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03399825
• Other study ID #: OCTA children
• Status: Withdrawn
• Start date: January 2018
• Est. completion date: March 1, 2018

Study information

• Verified date: September 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Device:
• OCT-A
optical coherence tomography angiography Imaging with optical coherence tomography angiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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