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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337332
Other study ID # RC 7-7-22
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 14, 2022
Est. completion date June 1, 2023

Study information

Verified date April 2022
Source Benha University
Contact Ahmed Abdelshafy, MD
Phone 01222328766
Email ahmad4lg@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.


Description:

Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 1, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery. Exclusion Criteria: - other retinal diseases that may affect CMT and final visual outcome. - Patients with dense corneal opacity.

Study Design


Intervention

Drug:
Triamcinolone Acetonide
Suprachoroidal injection of triamcinolone acetonide

Locations

Country Name City State
Egypt Ahmed Abdelshafy Banha QA

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Intraocular pressure Changes in intraocular pressure (IOP) measured in millimeter mercury (mmHg) by applanation tonometry. Baseline and 12 months after injection.
Primary Central macular thickness Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT) Baseline and 12 months after injection.
Secondary Best corrected visual acuity Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector. Baseline and 12 months after injection.
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