Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00532415

Purpose

Vitreous delineating agents are used in ophthalmic surgery to permit visualization of structures in the back of the eye to aid in their removal and improve safety of the surgery.

If you agree to participate in the study, your surgeon will inject the vitreous delineating agent inside your eye at some point during your surgery. When your surgeon no longer needs a visualization aid, the vitreous delineating agent will be removed from the inside of your eye as much as possible. If you decide to participate, this clinical study will last approximately one week.

Condition	Intervention	Phase
Vitrectomy	Procedure: Vitrectomy using triamcinolone acetonide	Phase III

Drug Information available for: Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of the Safety and Efficacy of Vitreous Delineating Agent for Visualization During Vitrectomy Surgery

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Masked reader evaluations of the visualization or posterior segment structures in pars plana vitrectomy before andn after instillation of the vitreous delineating agent. [ Time Frame: Procedure ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye. The study excludes patients with previous vitrectomy, elevated IOP and/or history of ocular inflammatory disease.

Exclusion Criteria:

Patients under 18

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532415

Locations

United States, Texas
Houston
Houston, Texas, United States, 77025

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Dana Sager, M.S.

Alcon Research

More Information

Study ID Numbers:	C-05-62
Study First Received:	September 19, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00532415
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Vitrectomy
Visualization

Study placed in the following topic categories:

Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Triamcinolone hexacetonide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009