Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

May 21, 2022 updated by: Ehab tharwat, Al-Azhar University

Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

The aim of this study is to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone in the management of macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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 Locations

  • Egypt
    • New Damietta
      • Damieta, New Damietta, Egypt, 34517
        • Ehab tharwat

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diminution vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch, as evidenced by clinical and angiographic evaluation
  • CMT ≥ 250 µ.
  • Willing to participate in the study

Exclusion Criteria:

  • Unwilling to participate in the study.
  • Ischemic RVO
  • Prior laser treatment
  • Glaucoma/Ocular Hypertension
  • Cataract which lead to difficulty in the evaluation of macula
  • Vitreous hemorrhage
  • Macular ischemia
  • Iris neovascularisation
  • patients with intravitreal injection of anti VEGFs, steroid, or any intraocular surgery 3 months prior to the inclusion.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Formulated Posterior Sub Tenon Triamcinolone
Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate
formulated with sodium hyaluronate and chondroitin sulfate
Active Comparator: Posterior Sub Tenon Triamcinolone alone
Drug: Triamcinolone Acetonide alone
Triamcinolone Acetonide alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity (BCVA)
Time Frame: Baseline
will be measured with the Snellen chart
Baseline
Best-corrected visual acuity (BCVA)
Time Frame: at 1st month
will be measured with the Snellen chart
at 1st month
Best-corrected visual acuity (BCVA)
Time Frame: at 3rd month
will be measured with the Snellen chart
at 3rd month
Best-corrected visual acuity (BCVA)
Time Frame: at 6th month
will be measured with the Snellen chart
at 6th month
central macular thickness ( CMT)
Time Frame: at baseline
CMT will be measured with OCT
at baseline
central macular thickness ( CMT)
Time Frame: at 1st month
CMT will be measured with OCT
at 1st month
central macular thickness ( CMT)
Time Frame: at 3rd month
CMT will be measured with OCT
at 3rd month
central macular thickness ( CMT)
Time Frame: at 6th month
CMT will be measured with OCT
at 6th month

Collaborators and Investigators

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

Sponsor

Al-Azhar 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)

January 2, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSTA and macular edema

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Macula Edema

Clinical Trials on Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe