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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-09-01

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A custom made Suprachoroidal needle for macular diseases

A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana

Group Type EXPERIMENTAL

Custom suorachoroidal needle

Intervention Type PROCEDURE

Custom made Supra Choroidal Space needle

Interventions

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Custom suorachoroidal needle

Custom made Supra Choroidal Space needle

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No