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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

Tracking Information
First Submitted Date January 8, 2018
First Posted Date January 16, 2018
Last Update Posted Date January 17, 2018
Estimated Study Start Date January 2018
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03399825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
Official Title Investigation of Vascular Pathology in Eye Diseases Using Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Retinopathy of Prematurity
  • Diabetic Retinopathy
Intervention Device: OCT-A

optical coherence tomography angiography

Imaging with optical coherence tomography angiography

Study Groups/Cohorts
  • Healthy controls
    Children without eye disease
    Intervention: Device: OCT-A
  • Retinopathy of prematurity (ROP)
    Previously preterm children with a history of ROP
    Intervention: Device: OCT-A
  • Diabetic retinopathy
    Children with diabetes
    Intervention: Device: OCT-A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 8, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Karen Schaal, MD +41316322501 karen.schaal@insel.ch
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03399825
Other Study ID Numbers OCTA children
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital Inselspital, Berne
Verification Date January 2018