Clinical trial NCT05140304: Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography
Official title: Quantitative and Qualitative Analysis of Foveal Avascular Zone Characteristics in Different Stages of Diabetic Retinopathy Using Optical Coherence Tomography Angiography (OCT-A)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuit Universoty
name: Ziad Hn El Daly, MD
role: STUDY_CHAIR
References:
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 Aug 5.
citation: 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.0081499. eCollection 2013.
citation: NOVOTNY HR, ALVIS DL. A method of photographing fluorescence in circulating blood in the human retina. Circulation. 1961 Jul;24:82-6. doi: 10.1161/01.cir.24.1.82. No abstract available.