Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

NCT ID: NCT03357146

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-09

Study Completion Date

2021-08-30

Brief Summary

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Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion with non-invasive, non-contact optical coherence tomography angiography.

Detailed Description

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Occlusion of the retinal arteries is an emergency which causes sudden, painless unilateral vision loss. Loss of blood flow causes ischemic damage to the retina. The extent of damage depends on the area affected.

Following the acute phase of the disease re-canalization occurs and lesser blood flow can be detected usually without functional recovery.

Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion.

Standard procedures to examine this disease include retinoscopy following pupil dilation, fluorescein angiography and more recently, optical coherence tomography (OCT).

The latest direction in OCT development was OCT angiography (OCTA) which is a software upgrade that allows detection of blood flow based on motion contrast. Similar to previous OCT machines OCTA is also non-invasive and non-contact and does not require any intravenous agents.

OCT machines are approved in the EU and the US and are not experimental devices.

The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex 5000 that operates with spectral-domain technology.

Conditions

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Retinal Artery Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CRA

Patients with chronic retinal artery occlusion

Optical coherence tomography angiography

Intervention Type DEVICE

OCTA scans per built-in device protocol

Control

Healthy

Optical coherence tomography angiography

Intervention Type DEVICE

OCTA scans per built-in device protocol

Interventions

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Optical coherence tomography angiography

OCTA scans per built-in device protocol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* central or branch retinal artery occlusion
* at least 6 months of onset
* signed informed consent

Exclusion Criteria

* known epilepsy
* incapacity
* presence of optical media opacities that would disturb the imaging
* presence of other retinal diseases that would disturb the evaluation of images
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Miklos Schneider MD, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miklos Schneider

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University, Department of Ophthalmology

Locations

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Semmelweis University, Department of Ophthalmology

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.

Reference Type BACKGROUND
PMID: 26457398 (View on PubMed)

Chalam KV, Sambhav K. Optical Coherence Tomography Angiography in Retinal Diseases. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):84-92. doi: 10.4103/2008-322X.180709.

Reference Type BACKGROUND
PMID: 27195091 (View on PubMed)

Jia Y, Bailey ST, Hwang TS, McClintic SM, Gao SS, Pennesi ME, Flaxel CJ, Lauer AK, Wilson DJ, Hornegger J, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of vascular abnormalities in the living human eye. Proc Natl Acad Sci U S A. 2015 May 5;112(18):E2395-402. doi: 10.1073/pnas.1500185112. Epub 2015 Apr 20.

Reference Type BACKGROUND
PMID: 25897021 (View on PubMed)

Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.

Reference Type BACKGROUND
PMID: 26469536 (View on PubMed)

Savastano MC, Lumbroso B, Rispoli M. IN VIVO CHARACTERIZATION OF RETINAL VASCULARIZATION MORPHOLOGY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2196-203. doi: 10.1097/IAE.0000000000000635.

Reference Type BACKGROUND
PMID: 25932558 (View on PubMed)

Spaide RF. VOLUME-RENDERED ANGIOGRAPHIC AND STRUCTURAL OPTICAL COHERENCE TOMOGRAPHY. Retina. 2015 Nov;35(11):2181-7. doi: 10.1097/IAE.0000000000000764.

Reference Type BACKGROUND
PMID: 26428608 (View on PubMed)

Yu S, Lu J, Cao D, Liu R, Liu B, Li T, Luo Y, Lu L. The role of optical coherence tomography angiography in fundus vascular abnormalities. BMC Ophthalmol. 2016 Jul 13;16:107. doi: 10.1186/s12886-016-0277-2.

Reference Type BACKGROUND
PMID: 27412442 (View on PubMed)

Other Identifiers

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RAO-OCTA-1253

Identifier Type: -

Identifier Source: org_study_id

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