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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06173245
Other study ID # MD/AZ.AST./OPH026/2/199/9/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2023

Study information

Verified date December 2023
Source Egyptian Biomedical Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME) with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating other factors.


Description:

Diabetes is a metabolic disorder affecting the ocular vasculature. Although the principal posterior segment changes in diabetes usually occur in the retinal vasculature, additional changes are also observed in the choroid which provides an important blood supply to the outer retina. Diabetic choroidopathy involves choroidal abnormalities occurring in diabetic patients and may participate in mechanisms that lead to the decrease of visual acuity. Several studies demonstrated the possibility of imaging of the choroid using spectral-domain OCT. Many studies investigated variation in the choroidal thickness (CT) occurring with changes in age and axial length, or in different ocular diseases, Diabetic macular edema (DME) is a major cause of visual loss in diabetic patients. OCT (Optical coherence tomography) is a non-invasive imaging technique, that was used to obtain a high definition segments of retina. Lately, EDI (enhanced depth imaging) spectral-domain OCT has been explained. (EDI) program routinely captures a cross sectional picture with the choroid near the zero delay line to enhance sensitivity on the external edge of the choroid. Functional imaging findings also presented a decrease in choroidal flow of the blood in eyes with diabetic retinopathy. The current purpose of (EDI-OCT), which employing the enhanced depth of field from the inverted picture by locating the OCT device near to the eye, has helped the researchers to study the anatomic variations in the choroid in diabetic eyes.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - Age from 50 to 70 years. - Both sexes. - Patients suffering from diabetic macular edema (DME). Exclusion Criteria: - High myopia more than 6 diopters. - previous injections or retinal surgery.

Study Design


Intervention

Procedure:
Intravitreal injection of ranibizumab
These patients were received three intravitreal injection of ranibizumab with one month interval. 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) was done preoperative and a month after every injection. All patients recieved topical anesthesia as 0.5 mg/0.05 ml , ranibizumab is injected 4 mm (3.5 mm in Pseudophakia) from the limbus intravitreally (in the lower temporal quadrant) by a needle (27gauge).

Locations

Country Name City State
Egypt Al-Azhar University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of subfoveal choroidal thickness (SFCT) All patients will be scheduled for subfoveal choroidal thickness (SFCT) evaluation on the first month, two month and three months by Optical coherence tomography (OCT). 3 months
Secondary Change of visual acuity (VA) Regular measurements of visual acuity (VA) over the evaluation visiting 3 months
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