NCT03264391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

January 13, 2021

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

August 25, 2017

Last Update Submit

January 12, 2021

Conditions

Keywords

OCT-ARetinal vasculitisBehcet's disease

Outcome Measures

Primary Outcomes (1)

  • Qualitative description of the retinal capillary plexus changes in the macular area

    1 year

Secondary Outcomes (1)

  • Correlation between extent of macular vascular changes and visual acuity

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Behcet's disease

You may qualify if:

  • Patients diagnosed with Behcet's disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 27715380BACKGROUND
  • 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.

    PMID: 18566457BACKGROUND
  • 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.

    PMID: 14744000BACKGROUND

Related Links

MeSH Terms

Conditions

Retinal VasculitisBehcet Syndrome

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

March 1, 2018

Primary Completion

December 30, 2019

Study Completion

January 31, 2020

Last Updated

January 13, 2021

Record last verified: 2020-05

Locations