Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

Retinal Artery Occlusion Clinical Trial

— RAO-OCTA  

Official title:

Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357146
• Other study ID #: RAO-OCTA-1253
• Status: Completed
• Start date: January 9, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Retinal Artery Occlusion

Intervention

Device:
• Optical coherence tomography angiography
OCTA scans per built-in device protocol

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary density in relation to healthy subjects		Through study completion, 1 year
Secondary	Correlation of capillary density and retinal thickness		Through study completion, 1 year