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

Study Overview
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Brief Summary
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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.

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

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Formulated Posterior Sub Tenon Triamcinolone<br>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. | Drug: Triamcinolone Acetonide<br>* Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Measured by snellen chart | at the base line | 
| Best corrected visual acuity | Measured by snellen chart | at 1st month | 
| Best corrected visual acuity | Measured by snellen chart | at 3rd month | 
| Best corrected visual acuity | Measured by snellen chart | at 6th month | 
| Central macular thickness | Measured by Optical coherence tomography (OCT) | at 1st month | 
| Central macular thickness | Measured by Optical coherence tomography (OCT) | at 3rd month | 
| Central macular thickness | Measured by Optical coherence tomography (OCT) | at 6th month |