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

NCT02811536 | Completed

• 1 other identifier: OCTA Bern
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of the sensitivity and specificity of OCTA

  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 years

Secondary Outcomes (3)

• Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA

  2 years

• OCTA and Fundus color photographs

  2 years

• Subgroup analysis

  2 years

Study Arms (8)

Diabetic retinopathy

Patients with various degrees of diabetic retinopathy

Device: optical coherence tomography angiography

Retinal detachment

Patients with a history of retinal detachment

Device: optical coherence tomography angiography

Retinal vein occlusion

Patients with a history of retinal vein occlusion

Device: optical coherence tomography angiography

Arterial hypertension

Patients with a history of arterial hypertension

Device: optical coherence tomography angiography

Carotid artery occlusion

Patients with a history of carotid artery occlusion

Device: optical coherence tomography angiography

Age related macular degeneration

Patients with a history of Age related macular degeneration

Device: optical coherence tomography angiography

Macroaneurysms

Patients with a history of retinal macroaneurysms

Device: optical coherence tomography angiography

Central serous chorioretinopathy

Patients with a history of central serous chorioretinopathy

Device: optical coherence tomography angiography

Interventions

optical coherence tomography angiography DEVICE

Imaging with optical coherence tomography angiography

Age related macular degeneration; Arterial hypertension; Carotid artery occlusion; Central serous chorioretinopathy; Diabetic retinopathy; Macroaneurysms; Retinal detachment; Retinal vein occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Location

Related Publications (2)

• Tian M, Zeng G, Zinkernagel M, Tappeiner C, Wolf S, Munk MR. Assessment of choriocapillaris and choroidal vascular changes in posterior uveitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2024 Feb 21;108(3):386-390. doi: 10.1136/bjo-2022-322209.

  PMID: 36627172 DERIVED

• 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.

  PMID: 30538102 DERIVED

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Martin Zinkernagel, Prof.MD PhD

  Inselspital, University Clinic for Ophthalmology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 23, 2016
• Study Start: February 13, 2017
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)