Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532415
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : April 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vitrectomy Drug: Triamcinolone Acetonide Injectable Suspension Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery
Study Start Date : September 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Triamcinolone
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 18.
  • Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.
  • Other protocol-defined exclusion criteria may apply.

Responsible Party: Alcon Research Identifier: NCT00532415     History of Changes
Other Study ID Numbers: C-05-62
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action