Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography

Diabetic Retinopathy Clinical Trial

Official title:

Quantitative and Qualitative Analysis of Foveal Avascular Zone Characteristics in Different Stages of Diabetic Retinopathy Using Optical Coherence Tomography Angiography (OCT-A)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05140304
• Other study ID #: OCT angiography
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: November 2022

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: Kareem Md Ali, Resident
• Phone: +201091319590
• Email: kmasms2712[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using OCTA.

Description:

OCTA is superior to other retinal imaging techniques like fluorescein angiography(FA) as it does not require dye injection, Intravenous dye injection is time consuming and can have adverse side effects. Furthermore, the edges of the capillaries can become blurred due to dye leakage and imaging of the retina can only be 2D when using FA.

OCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.

In diabetic retinopathy OCTA can show choriocapillaris abnormalities and/or retinal microvascular abnormalities such as microaneurysms, vascular remodeling adjacent to the foveal avascular zone (FAZ), enlarged FAZ, and capillary tortuosity and dilation through different stages. OCTA can show smaller vascular changes not detectable by FA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Diabetic patients suffering from different stages of diabetic retinopathy.

Exclusion Criteria:

• Other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• OCT angiography
OCT angiography of foveal avascular zone in diabetic retinopathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kareem Mohammad Ali

References & Publications (3)

Choi W, Mohler KJ, Potsaid B, Lu CD, Liu JJ, Jayaraman V, Cable AE, Duker JS, Huber R, Fujimoto JG. Choriocapillaris and choroidal microvasculature imaging with ultrahigh speed OCT angiography. PLoS One. 2013 Dec 11;8(12):e81499. doi: 10.1371/journal.pone — View Citation

Kim DY, Fingler J, Zawadzki RJ, Park SS, Morse LS, Schwartz DM, Fraser SE, Werner JS. Optical imaging of the chorioretinal vasculature in the living human eye. Proc Natl Acad Sci U S A. 2013 Aug 27;110(35):14354-9. doi: 10.1073/pnas.1307315110. Epub 2013 — View Citation

NOVOTNY HR, ALVIS DL. A method of photographing fluorescence in circulating blood in the human retina. Circulation. 1961 Jul;24:82-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses	analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography	baseline