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.
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.
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:
- Inclusion criteria:
- Patients diagnosed with Behcet's disease with or without active uveitis
- Exclusion criteria:
- Patients less than 18 years old
- Hazy media precluding clear fundus view.
- Patients with very poor fixation.
- 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:
- 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.
- Thorough clinical history and review of other systems involvement as well as full drug history including use of topical and systemic medications.
- 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:
- Primary (main):
1- Qualitative description of the retinal capillary plexus changes in the macular area
- Secondary:
- Quantification of the extent of macular ischemia by measuring the area of foveal avascular zone (FAZ).
- 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
- Conditions
- Retinal Vasculitis, Behcet Syndrome
- 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.
Qualitative description of the retinal capillary plexus changes in the macular area
Measured: 1 year
Secondary outcomes (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.
- First posted29 Aug 2017
- Study start1 Mar 2018
- Primary completion30 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal VasculitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatallah Saleh, Assiut University
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 27715380Fingler 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 18566457Leitgeb 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT03264391
- Acronym / sponsor ID
- 17100296
- Conditions
- Retinal Vasculitis, Behcet Syndrome
- Keywords
- OCT-A, Retinal vasculitis, Behcet's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Inclusion criteria:
- Patients diagnosed with Behcet's disease with or without active uveitis
- Exclusion criteria:
- Patients less than 18 years old
- Hazy media precluding clear fundus view.
- Patients with very poor fixation.
- 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:
- 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.
- Thorough clinical history and review of other systems involvement as well as full drug history including use of topical and systemic medications.
- 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:
- Primary (main):
1- Qualitative description of the retinal capillary plexus changes in the macular area
- Secondary:
- Quantification of the extent of macular ischemia by measuring the area of foveal avascular zone (FAZ).
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Behcet's disease
Key inclusion criteria (1 listed)
- • Patients diagnosed with Behcet's disease
Key exclusion criteria (3 listed)
- • Patients less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative description of the retinal capillary plexus changes in the macular area
Time frame: 1 year
1 secondary outcome
Correlation between extent of macular vascular changes and visual acuity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 27715380Bazvand 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.
- Background: PubMed 18566457Fingler 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.
- Background: PubMed 14744000Leitgeb 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.