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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03264391
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
Menatallah Saleh, Assiut University

Brief 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. 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.

Condition or disease
Retinal Vasculitis Behcet Syndrome

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Primary Outcome Measures :
  1. Qualitative description of the retinal capillary plexus changes in the macular area [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Correlation between extent of macular vascular changes and visual acuity [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Behcet's disease

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.

Additional Information:
Responsible Party: Menatallah Saleh, Principal Investigator, Assiut University Identifier: NCT03264391     History of Changes
Other Study ID Numbers: 17100296
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Menatallah Saleh, Assiut University:
Retinal vasculitis
Behcet's disease

Additional relevant MeSH terms:
Behcet Syndrome
Retinal Vasculitis
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Retinal Diseases