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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT02811536
Collaborator
(none)
550
1
69.6
7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Feb 13, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the sensitivity and specificity of OCTA [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 [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 [2 years]

    Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA

  3. Subgroup analysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inselspital Bern, Department of Ophthalmology Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02811536
Other Study ID Numbers:
  • OCTA Bern
First Posted:
Jun 23, 2016
Last Update Posted:
Sep 13, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2019