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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 : Unknown
Verified May 2017 by University Hospital Inselspital, Berne.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : May 2, 2017
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

Condition or disease Intervention/treatment
Retinal Disease Device: optical coherence tomography angiography

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 : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diabetic retinopathy
Patients with various degrees of diabetic retinopathy
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Retinal detachment
Patients with a history of retinal detachment
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Retinal vein occlusion
Patients with a history of retinal vein occlusion
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Arterial hypertension
Patients with a history of arterial hypertension
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Carotid artery occlusion
Patients with a history of carotid artery occlusion
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Age related macular degeneration
Patients with a history of Age related macular degeneration
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Macroaneurysms
Patients with a history of retinal macroaneurysms
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Central serous chorioretinopathy
Patients with a history of central serous chorioretinopathy
Device: 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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, 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
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


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): NCT02811536


Contacts
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Contact: Martin S ZINKERNAGEL, MD, PhD +41316329565 martin.zinkernagel@insel.ch
Contact: Corinne Stöckli +41316329565 corinne.stöckli@insel.ch

Locations
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Switzerland
Inselspital Bern, Department of Ophthalmology Recruiting
Bern, Switzerland, 3010
Contact: Martin Zinkernagel, MD, PhD    +41316329565    martin.zinkernagel@insel.ch   
Contact: Corinne Stöckli    +41316321197    corinne.stoeckli@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02811536     History of Changes
Other Study ID Numbers: OCTA Bern
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Eye Diseases
Retinal Diseases