Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

Phase 3

Completed

• Conditions: Vitrectomy
• Interventions: Drug: Triamcinolone Acetonide Injectable Suspension

• Registration Number: NCT00532415
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-20
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 18.
• Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triamcinolone	Triamcinolone Acetonide Injectable Suspension	Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.

Primary Outcome Measures

Name	Time	Method
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation	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.