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Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)

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ClinicalTrials.gov Identifier: NCT02811536
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 23, 2016
Last Update Posted Date September 13, 2019
Actual Study Start Date February 13, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2017)
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
 (submitted: June 20, 2016)
Evaluation of the sensitivity and specificity of OCTA [ Time Frame: 2 years ]
The primary objective of this observational study is to evaluate if diagnosis of various eye diseases can be improved by using an optical coherence tomography angiography. Evaluation of the sensitivity and specificity of OCTA compared to conventional imaging methods.
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2017)
  • Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using 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.
  • OCTA and Fundus color photographs [ Time Frame: 2 years ]
    Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA
  • Subgroup analysis [ Time Frame: 2 years ]
    Subgroup analysis will be performed with patients suffering from diabetic retinopathy, artery occlusion, carotid stenosis, retinal detachment, vein occlusion, age related macular degeneration, retinal changes from arterial hypertension, retinal macroaneurysms and uveitis.
Original Secondary Outcome Measures
 (submitted: June 20, 2016)
  • Evaluation of the sensitivity and specificity of OCTA combined with fundus color photography, and of fluorescein angiography combined with fundus color photography. [ Time Frame: 2 years ]
  • Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
Official Title Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
Brief Summary Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases
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: Cohort
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, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular macroaneurysma, and diabetic macular edema and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
Condition Retinal Disease
Intervention Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography
Study Groups/Cohorts
  • Diabetic retinopathy
    Patients with various degrees of diabetic retinopathy
    Intervention: Device: optical coherence tomography angiography
  • Retinal detachment
    Patients with a history of retinal detachment
    Intervention: Device: optical coherence tomography angiography
  • Retinal vein occlusion
    Patients with a history of retinal vein occlusion
    Intervention: Device: optical coherence tomography angiography
  • Arterial hypertension
    Patients with a history of arterial hypertension
    Intervention: Device: optical coherence tomography angiography
  • Carotid artery occlusion
    Patients with a history of carotid artery occlusion
    Intervention: Device: optical coherence tomography angiography
  • Age related macular degeneration
    Patients with a history of Age related macular degeneration
    Intervention: Device: optical coherence tomography angiography
  • Macroaneurysms
    Patients with a history of retinal macroaneurysms
    Intervention: Device: optical coherence tomography angiography
  • Central serous chorioretinopathy
    Patients with a history of central serous chorioretinopathy
    Intervention: Device: optical coherence tomography angiography
Publications * Tian M, Tappeiner C, Zinkernagel MS, Huf W, Wolf S, Munk MR. Evaluation of vascular changes in intermediate uveitis and retinal vasculitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2019 Sep;103(9):1289-1295. doi: 10.1136/bjophthalmol-2018-313078. Epub 2018 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 20, 2016)
550
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older

Exclusion criteria:

Patients not willing or able to sign informed consent Patients younger than 18 years Patients with epilepsy Patients having had photodynamic therapy within the last 48 hours prior to imaging with OCTA

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Martin S ZINKERNAGEL, MD, PhD +41316329565 martin.zinkernagel@insel.ch
Contact: Corinne Stöckli +41316329565 corinne.stöckli@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02811536
Other Study ID Numbers OCTA Bern
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
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 September 2019