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AzTrials

Retinal VasculitisNCT03264391

Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography

An observational study of Retinal Vasculitis and Behcet Syndrome, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt. Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT angiography (OCT-A) is a recently developed method that can be used in the evaluation of retinal circulation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Vasculitis, Behcet Syndrome
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Mar 2018to 31 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with Behcet's disease

Who may be able to join

  • • Patients diagnosed with Behcet's disease

Who cannot join

  • • Patients less than 18 years old
  • Hazy media precluding clear fundus view.
  • Patients with very poor fixation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine

    Asyut

Other trials in Egypt

About this study

Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt. Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT angiography (OCT-A) is a recently developed method that can be used in the evaluation of retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and hence prognosis will be described.

Read the detailed description

Aim of the research To describe macular retinal vascular changes in patient with retinal vasculitis secondary to Behcet's disease both qualitatively and quantitatively.

Research design Type of the study: cross sectional analytical study Study Setting: Assuit University Hospital (Ophthalmology Department)

Study subjects:

  1. Inclusion criteria:
  • Patients diagnosed with Behcet's disease with or without active uveitis
  1. Exclusion criteria:
  • Patients less than 18 years old
  • Hazy media precluding clear fundus view.
  • Patients with very poor fixation.
  1. Sample Size Calculation:

We will aim at recruiting all patients diagnosed with Behcet's disease in outpatient clinic who will meet the inclusion criteria within one year from the start of our project.

Methods Subject recruitment and obtaining consent Study subjects (Behcet's patients) will be recruited from patients attending uveitis and retina clinic of the ophthalmology Department, Faculty of Medicine, Assiut University. Written informed consent form will be obtained from each patient.

Baseline evaluation:

  1. Full ocular examination including slit lamp and dilated fundus examinations. Also, measurement of the best corrected visual acuity (BCVA) using Snellen's chart will be done.
  2. Thorough clinical history and review of other systems involvement as well as full drug history including use of topical and systemic medications.
  3. Retinal vasculitis will be diagnosed by fundus examination. Additionally, fluorescein angiography may be done according to the discretion of the investigators to confirm the diagnosis.

Optical coherence tomography angiography imaging OCT imaging will be performed after pupillary dilatation using Topcon DRI OCT Triton platform which utilizes invisible 1050 nm light and obtains images at a speed of 100,000 A scans/sec.

First, B scans of the macula will be obtained and anatomical alterations of retinal architecture will be noted. Next, OCT angiography scans in a 4.5x 4.5 mm circle centered on the fovea will be then obtained. Analysis and interpretation of the enface images of the superficial and deep retinal capillary plexus as well as choriocapillaries will be performed. Areas of capillary dropout, abnormalities of retinal capillaries and vessels such as looping, dilated segments, microaneurysms as well as FAZ area will be documented.

Research outcome measures:

  1. Primary (main):

1- Qualitative description of the retinal capillary plexus changes in the macular area

  1. Secondary:
  2. Quantification of the extent of macular ischemia by measuring the area of foveal avascular zone (FAZ).
  3. Correlation between extent of macular vascular changes and visual acuity

Data management and analysis:

Data collection data will be recorded in the form of excel spreadsheets Computer software SPSS and Prism graphpad Statistical tests chi square test and Pearson correlation coefficient

Keywords
OCT-A, Retinal vasculitis, Behcet's disease
Medical subject headings
Retinal Vasculitis, Behcet Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Qualitative description of the retinal capillary plexus changes in the macular area

    Measured: 1 year

Secondary outcomes (1)
  1. Correlation between extent of macular vascular changes and visual acuity

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 Mar 2018
  3. Primary completion30 Dec 2019
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03264391
Sponsor's protocol ID
17100296
Status last verified
May 2020
First submitted
25 Aug 2017
Last updated
13 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bazvand F, Zarei M, Ebrahimiadib N, Karkhaneh R, Davoudi S, Soleimanzadeh M, Sharifian E, Roohipoor R, Modjtahedi BS. Ocular Manifestations, Conventional Fundus Fluorescein Angiographic Findings, and Relationship Between Angiographic Findings and Visual Acuity in Behcet's Disease. Semin Ophthalmol. 2017;32(6):764-771. doi: 10.1080/08820538.2016.1178310. Epub 2016 Aug 10.

    PubMed 27715380
  • Fingler J, Readhead C, Schwartz DM, Fraser SE. Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):5055-9. doi: 10.1167/iovs.07-1627. Epub 2008 Jun 19.

    PubMed 18566457
  • Leitgeb RA, Schmetterer L, Hitzenberger CK, Fercher AF, Berisha F, Wojtkowski M, Bajraszewski T. Real-time measurement of in vitro flow by Fourier-domain color Doppler optical coherence tomography. Opt Lett. 2004 Jan 15;29(2):171-3. doi: 10.1364/ol.29.000171.

    PubMed 14744000

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Vasculitis and Behcet Syndrome, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative description of the retinal capillary plexus changes in the macular area (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03264391, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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