Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders

Study Overview
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Brief Summary
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Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.

Detailed Description
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A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.

Official Title
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Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis

Conditions
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Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis

Intervention / Treatment
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* Procedure: Custom suorachoroidal needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years and older Patients with macular edema or degeneration from various pathologies Central macular thickness more than 250 microns Patients who are able to come for all follow-up Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 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
Interventional Model Description: Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A custom made Suprachoroidal needle for macular diseases<br>A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana | Procedure: Custom suorachoroidal needle<br>* Custom made Supra Choroidal Space needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieved visual acuity improvement | To measure best corrected visual acuity using using Snellen chart or equivalent | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Central macular thickness reduction in microns | Using optical coherence tomography in monthly bases to measure central retinal thickness | 12 weeks | 
| Proportion of eyes with Increased intraocular pressure | To measure intraocular pressure using Goldmann applanation tonometer | 12 weeks |