ClinicalTrials.gg
CompletedNCT03357146RAO-OCTAUpdated Oct 6, 2021

Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

An observational study in Retinal Artery Occlusion, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Semmelweis University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
42
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Retinal Artery Occlusion
03

In context

Retinal Artery Occlusion

31 studies on the registry are indexed under Retinal Artery Occlusion; 7 are open to participants now.

This study's enrollment of 42 is below the median of 388 across 14 observational studies indexed under Retinal Artery Occlusion.

Browse Retinal Artery Occlusion studies →

Lead sponsor

Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

White caucasias

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • central or branch retinal artery occlusion
  • at least 6 months of onset
  • signed

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
42 participants (actual)
Patient registry
No

Groups and cohorts

  • CRA

    Patients with chronic retinal artery occlusion

    Device: Optical coherence tomography angiography

  • Control

    Healthy

    Device: Optical coherence tomography angiography

Interventions

  • DeviceOptical coherence tomography angiography

    OCTA scans per built-in device protocol

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What researchers measure

Primary outcomes

  1. Capillary density in relation to healthy subjects

    Time frame: Through study completion, 1 year

Secondary outcomes

  1. Correlation of capillary density and retinal thickness

    Time frame: Through study completion, 1 year

07

Study locations

1 site
  • Semmelweis University, Department of Ophthalmology
    Budapest, 1085, Hungary
08

References and documents

Publications

  • 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. PubMed 26457398 ↗
  • 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. PubMed 27195091 ↗
  • 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. PubMed 25897021 ↗
  • 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. PubMed 26469536 ↗
  • 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. PubMed 25932558 ↗
  • Spaide RF. VOLUME-RENDERED ANGIOGRAPHIC AND STRUCTURAL OPTICAL COHERENCE TOMOGRAPHY. Retina. 2015 Nov;35(11):2181-7. doi: 10.1097/IAE.0000000000000764. PubMed 26428608 ↗
  • 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. PubMed 27412442 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Aug 2018, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2017
First posted
Nov 29, 2017
StartActual
Jan 9, 2017
Primary completionActual
Aug 30, 2018
CompletionActual
Aug 30, 2021
Last update
Oct 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03357146
Responsible party
Miklos Schneider MD, PhD (Assistant Professor, Semmelweis University) — Principal investigator
First posted
Nov 29, 2017
Start date
Jan 9, 2017
Primary completion
Aug 30, 2018
Completion
Aug 30, 2021
Last update
Oct 6, 2021

Study contacts

Miklos Schneider
principal investigator · Semmelweis University, Department of Ophthalmology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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