Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography

Sponsor
Kareem Mohammad Ali (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05140304
Collaborator
(none)
50
1
11

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: OCT angiography
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Quantitative and Qualitative Analysis of Foveal Avascular Zone Characteristics in Different Stages of Diabetic Retinopathy Using Optical Coherence Tomography Angiography (OCT-A)
Anticipated Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: A

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

Outcome Measures

Primary Outcome Measures

  1. Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses [baseline]

    analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kareem Mohammad Ali

Investigators

  • Study Chair: Ziad Hn El Daly, MD, Assuit Universoty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kareem Mohammad Ali, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05140304
Other Study ID Numbers:
  • OCT angiography
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021