Back to resultsAnalysis of FAZ in Diabetic Retinopathy Using OCT Angiography
Primary Purpose
Diabetic Retinopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OCT angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Retinopathy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05140304
First Posted
November 17, 2021
Last Updated
November 17, 2021
Sponsor
Kareem Mohammad Ali
1. Study Identification
Unique Protocol Identification Number
NCT05140304
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kareem Mohammad Ali
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
OCT angiography
Intervention Description
OCT angiography of foveal avascular zone in diabetic retinopathy
Primary Outcome Measure Information:
Title
Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses
Description
analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem Md Ali, Resident
Phone
+201091319590
Email
kmasms2712@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ziad Hn El Daly, MD
Phone
+201091319590
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Hn El Daly, MD
Organizational Affiliation
Assuit Universoty
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23918361
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.
Results Reference
result
PubMed Identifier
24349078
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.
Results Reference
result
PubMed Identifier
13729802
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.
Results Reference
result
Learn more about this trial
Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography
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