Clinical Evaluation of a New Viscoelastic for Cataract Surgery
The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of a New Viscoelastic for Cataract Surgery|
- Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively [ Time Frame: 3 months postoperative ] [ Designated as safety issue: Yes ]Cumulative rate of IOP spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
- Adverse Events [ Time Frame: Cumulative ] [ Designated as safety issue: Yes ]All adverse events regardless of severity were reported. Adverse events were considered serious if they were sight or life threatening, resulted in permenant implairment of a body function or structure (i.e. of the eye) or required medical or surgical intervention to prevent further impairment.
|Study Start Date:||September 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Vitrax II
Investigational dispersive viscoelastic
Device: Vitrax II
Viscoelastic adminstered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
Active Comparator: Viscoat
Marketed control dispersive viscoelastic
Currently marketed viscoelastic adminstered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..