Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00532415
First received: September 19, 2007
Last updated: April 3, 2012
Last verified: April 2012

September 19, 2007
April 3, 2012
September 2007
September 2007   (final data collection date for primary outcome measure)
Change in Mean Visualization Score at Post-Instillation from Pre-Instillation [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT00532415 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Vitrectomy
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.
Experimental: Triamcinolone
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
Intervention: Drug: Triamcinolone Acetonide Injectable Suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00532415
C-05-62
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
April 2012

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