Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

NCT ID: NCT00532415

Last Updated: 2012-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-09-30

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.

Conditions

Vitrectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Triamcinolone

Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide Injectable Suspension

Intervention Type: DRUG

Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.

Exclusion Criteria

• Patients under 18.
• Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C-05-62

Identifier Type: -

Identifier Source: org_study_id