Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 60
- Primary Endpoint
- Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Patients under
- •Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
Triamcinolone
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
Intervention: Triamcinolone Acetonide Injectable Suspension (Drug)
Outcomes
Primary Outcomes
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation
Time Frame: Day 0
A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.
Secondary Outcomes
No secondary outcomes reported