Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Not Applicable
Completed
- Conditions
- Cataract
- Interventions
- Device: ViscoatDevice: Vitrax II
- Registration Number
- NCT00972621
- Lead Sponsor
- Abbott Medical Optics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Otherwise healthy eye with no pathology other than the presence of cataract
- Visual potential of 20/40 or better
Exclusion Criteria
- Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
- Known intraocular pressure increases from steroid treatment
- Low endothelial cell count
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Viscoat Viscoat Marketed control dispersive viscoelastic Vitrax II Vitrax II Investigational dispersive viscoelastic
- Primary Outcome Measures
Name Time Method Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively 3 months postoperative Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
- Secondary Outcome Measures
Name Time Method Postoperative Mean Endothelial Cell Count 3 months postoperative mean endothelial cell count (measured by Konan specular microscope) at 3 months
Trial Locations
- Locations (1)
AMO Clinical Research Call Center for Trial Locations
🇺🇸Santa Ana, California, United States