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

January 12, 2021 updated by: Menatallah Saleh, Assiut University
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.

Study Overview

Status

Completed

Conditions

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

  2. Exclusion criteria:

    • Patients less than 18 years old
    • Hazy media precluding clear fundus view.
    • Patients with very poor fixation.
  3. 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:

A. Primary (main):

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

B. Secondary:

  1. Quantification of the extent of macular ischemia by measuring the area of foveal avascular zone (FAZ).
  2. 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

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Behcet's disease

Description

Inclusion Criteria:

  • • Patients diagnosed with Behcet's disease

Exclusion Criteria:

  • • Patients less than 18 years old

    • Hazy media precluding clear fundus view.
    • Patients with very poor fixation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Qualitative description of the retinal capillary plexus changes in the macular area
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between extent of macular vascular changes and visual acuity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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