Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
- Sponsor
- Marashi Eye Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Proportion of patients achieved visual acuity improvement
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Ameen Marashi
Principle investigator
Marashi Eye Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of patients achieved visual acuity improvement
Time Frame: 12 weeks
To measure best corrected visual acuity using using Snellen chart or equivalent
Secondary Outcomes
- Amount of Central macular thickness reduction in microns(12 weeks)
- Proportion of eyes with Increased intraocular pressure(12 weeks)