Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 19, 2007

Last Updated Date

July 25, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00532415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

Official Title ^ICMJE

Clinical Evaluation of the Safety and Efficacy of Vitreous Delineating Agent for Visualization During Vitrectomy Surgery

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vitrectomy

Intervention ^ICMJE

Procedure: Vitrectomy using triamcinolone acetonide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00532415

Responsible Party

Study ID Numbers ^ICMJE

C-05-62

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Dana Sager, M.S.

Alcon Research

Information Provided By

Alcon Research

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP