Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

Vitrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532415
• Other study ID #: C-05-62
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2007
• Last updated: April 3, 2012
• Start date: September 2007
• Est. completion date: September 2007

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitrectomy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Visualization Score at Post-Instillation from Pre-Instillation	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.	Day 0	No