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

NCT03399825 | Withdrawn

• 1 other identifier: OCTA children
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Retinopathy of Prematurity; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Healthy controls

Children without eye disease

Device: OCT-A

Retinopathy of prematurity (ROP)

Previously preterm children with a history of ROP

Device: OCT-A

Diabetic retinopathy

Children with diabetes

Device: OCT-A

Interventions

OCT-A DEVICE

optical coherence tomography angiography Imaging with optical coherence tomography angiography

Diabetic retinopathy; Healthy controls; Retinopathy of prematurity (ROP)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Retinopathy of Prematurity; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: January 1, 2018
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 17, 2019

Record last verified: 2019-09