Clinical Evaluation of a New Viscoelastic for Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT00972621|
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : February 22, 2012
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Vitrax II Device: Viscoat||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Evaluation of a New Viscoelastic for Cataract Surgery|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Vitrax II
Investigational dispersive viscoelastic
Device: Vitrax II
Viscoelastic administered 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 administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..
- Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively [ Time Frame: 3 months postoperative ]Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
- Postoperative Mean Endothelial Cell Count [ Time Frame: 3 months postoperative ]mean endothelial cell count (measured by Konan specular microscope) at 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972621
|United States, California|
|AMO Clinical Research Call Center for Trial Locations|
|Santa Ana, California, United States, 92799|