Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions

Not Applicable

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Triamcinolone Acetonide

• Registration Number: NCT05345808
• Lead Sponsor: Al-Azhar University

Brief Summary

Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-02-20
• Study Completion: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
• CMT ≥ 250 µ,
• Willing to participate in the study.

Exclusion Criteria

• Unwilling to participate in the study
• Ischemic RVO
• previous laser treatment
• Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
• patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion
• Cardiac co-morbidities result in significant hemodynamic changes
• Respiratory diseases need treatment with antibiotics
• Suffering from other chronic diseases as diabetes
• Patient with allergy from triamcinolone acetonide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Formulated Posterior Sub Tenon Triamcinolone	Triamcinolone Acetonide	All the eyes received single dose 40 mg of Triamcinolone Acetonide (TA) and VISCOAT which is 20 mg sodium chondroitin sulphate and 15 mg sodium hyaluronate (0.5 ml) through posterior subtenon route using NAGATA subtenon canula.

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	at 6th month	Measured by snellen chart
Central macular thickness	at 6th month	Measured by Optical coherence tomography (OCT)

Trial Locations

Locations (1)

Akram Fekry Elgazzar; 🇪🇬 Damietta, Egypt