Skip to main content
Clinical Trials/NCT00532415
NCT00532415CompletedPhase 3

Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery

Alcon Research0 sites60 target enrollmentStarted: September 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Experimental

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials