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..
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972621
|United States, California|
|AMO Clinical Research Call Center for Trial Locations|
|Santa Ana, California, United States, 92799|