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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Clinical Evaluation of the Safety and Efficacy of Vitreous Delineating Agent for Visualization During Vitrectomy Surgery

Resource links provided by NLM:

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

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Alcon Research:

Vitrectomy
Visualization

Additional relevant MeSH terms:

Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012