Changes After Suprachoroidal Injection.

March 11, 2022 updated by: Ahmed Abdelshafy, Benha University

Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.

Changes after suprachoroidal injection are analyzed for statistical analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Benha University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmed Abdelshafy, MD
        • Sub-Investigator:
          • Marwa Abdelshafy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in visual acuity
Time Frame: Monthly after injection till six months of follow up
Changes in best corrected visual acuity after injection
Monthly after injection till six months of follow up
Changes in central foveal thickness
Time Frame: Monthly after injection till six months of follow up
Changes in central macular thickness after injection
Monthly after injection till six months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in intraocular pressure
Time Frame: Monthly after injection till six months of follow up
Changes in intraocular pressure after injection
Monthly after injection till six months of follow up
Changes in lens
Time Frame: Monthly after injection till six months of follow up
Cataract progression after injection
Monthly after injection till six months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc-3-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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