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

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ClinicalTrials.gov Identifier: NCT03399825
Recruitment Status : Not yet recruiting
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment
Retinopathy of Prematurity Diabetic Retinopathy Device: OCT-A

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of Vascular Pathology in Eye Diseases Using Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Group/Cohort Intervention/treatment
Healthy controls
Children without eye disease
Device: OCT-A

optical coherence tomography angiography

Imaging with optical coherence tomography angiography


Retinopathy of prematurity (ROP)
Previously preterm children with a history of ROP
Device: OCT-A

optical coherence tomography angiography

Imaging with optical coherence tomography angiography


Diabetic retinopathy
Children with diabetes
Device: OCT-A

optical coherence tomography angiography

Imaging with optical coherence tomography angiography





Primary Outcome Measures :
  1. Evaluation of the sensitivity and specificity of OCTA [ Time Frame: 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.



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399825


Contacts
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Contact: Karen Schaal, MD +41316322501 karen.schaal@insel.ch

Sponsors and Collaborators
University Hospital Inselspital, Berne

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03399825     History of Changes
Other Study ID Numbers: OCTA children
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Retinopathy of Prematurity
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases