Back to resultsChanges After Suprachoroidal Injection.
Primary Purpose
Retina; Change, Intraocular Pressure, Cataract
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suprachoroidal triamcinolone acetonide (SCTA) injection
Sponsored by
About this trial
This is an interventional treatment trial for Retina; Change
Eligibility Criteria
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.
Sites / Locations
- Benha UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Suprachoroidal triamcinolone injection
Non-treated eyes
Arm Description
Eyes treated with suprachoroidal injection of triamcinolone acetonide.
Eyes that are receiving no interventions during the study period.
Outcomes
Primary Outcome Measures
Changes in visual acuity
Changes in best corrected visual acuity after injection
Changes in central foveal thickness
Changes in central macular thickness after injection
Secondary Outcome Measures
Changes in intraocular pressure
Changes in intraocular pressure after injection
Changes in lens
Cataract progression after injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05288192
Brief Title
Changes After Suprachoroidal Injection.
Official Title
Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Changes after suprachoroidal injection are analyzed for statistical analysis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina; Change, Intraocular Pressure, Cataract, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suprachoroidal triamcinolone injection
Arm Type
Active Comparator
Arm Description
Eyes treated with suprachoroidal injection of triamcinolone acetonide.
Arm Title
Non-treated eyes
Arm Type
No Intervention
Arm Description
Eyes that are receiving no interventions during the study period.
Intervention Type
Drug
Intervention Name(s)
Suprachoroidal triamcinolone acetonide (SCTA) injection
Other Intervention Name(s)
SCTA injection
Intervention Description
Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.
Primary Outcome Measure Information:
Title
Changes in visual acuity
Description
Changes in best corrected visual acuity after injection
Time Frame
Monthly after injection till six months of follow up
Title
Changes in central foveal thickness
Description
Changes in central macular thickness after injection
Time Frame
Monthly after injection till six months of follow up
Secondary Outcome Measure Information:
Title
Changes in intraocular pressure
Description
Changes in intraocular pressure after injection
Time Frame
Monthly after injection till six months of follow up
Title
Changes in lens
Description
Cataract progression after injection
Time Frame
Monthly after injection till six months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Ext
Abdelshafy
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
First Name & Middle Initial & Last Name & Degree
Marwa Abdelshafy, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Changes After Suprachoroidal Injection.
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