Changes After Suprachoroidal Injection.

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05288192
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

Changes after suprachoroidal injection are analyzed for statistical analysis.

Condition or Disease	Intervention/Treatment	Phase
Retina; Change; Intraocular Pressure; Cataract; Macular Edema	Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection	N/A

Detailed Description

Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.
• Actual Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Suprachoroidal triamcinolone injection Eyes treated with suprachoroidal injection of triamcinolone acetonide.	Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection; Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.; Other Names: SCTA injection
No Intervention: Non-treated eyes Eyes that are receiving no interventions during the study period.

Outcome Measures

Primary Outcome Measures

1. Changes in visual acuity [Monthly after injection till six months of follow up]

   Changes in best corrected visual acuity after injection

2. Changes in central foveal thickness [Monthly after injection till six months of follow up]

   Changes in central macular thickness after injection

Secondary Outcome Measures

1. Changes in intraocular pressure [Monthly after injection till six months of follow up]

   Changes in intraocular pressure after injection

2. Changes in lens [Monthly after injection till six months of follow up]

   Cataract progression after injection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.

• Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.

Exclusion Criteria:

• Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.

• Choroidal neovascularization that require anti-vascular endothelial growth factors.

• Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benha University	Banhā	QA	Egypt	13511

Sponsors and Collaborators

• Benha University

Investigators

• Principal Investigator: Ahmed A Tabl, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
• ClinicalTrials.gov Identifier: NCT05288192
• Other Study ID Numbers: Rc-3-22
• First Posted: Mar 21, 2022
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• 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: Cataract; Macular Edema; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate

Study Results

No Results Posted as of Mar 21, 2022