Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)

Not Applicable

• Conditions: Diabetic Macular Edema; Vogt Koyanagi Harada Disease; Retinal Vein Occlusion
• Interventions: Drug: Suprachoroidal triamcinolone acetonide injection

• Registration Number: NCT05496530
• Lead Sponsor: Benha University

Brief Summary

Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.

Detailed Description

In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.

Study Timeline

• Study Start: 2022-07-10
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
• Diabetic macular edema
• Vogt-koyanagi Harada disease
• Retinal vein occlusion.

Exclusion Criteria

• other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
• Cases with confirmed diagnosis of glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic macular edema	Suprachoroidal triamcinolone acetonide injection	Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.
Retinal vein occlusion	Suprachoroidal triamcinolone acetonide injection	Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.
Vogt-koyanagi harada	Suprachoroidal triamcinolone acetonide injection	Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.

Primary Outcome Measures

Name	Time	Method
Visual acuity	Baseline and up to one year after injection.	Changes noted in vision after injection measured 8n logMar units by snellen chart.

Secondary Outcome Measures

Name	Time	Method
Central macular thickness	Baseline and up to one year after injection.	Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.

Trial Locations

Locations (1)

Ahmed Abdelshafy Tabl; 🇪🇬 Banhā, Benha, Egypt