Back to resultsClinical Evaluation of a New Viscoelastic for Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitrax II
Viscoat
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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
Sites / Locations
- AMO Clinical Research Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitrax II
Viscoat
Arm Description
Investigational dispersive viscoelastic
Marketed control dispersive viscoelastic
Outcomes
Primary Outcome Measures
Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
Secondary Outcome Measures
Postoperative Mean Endothelial Cell Count
mean endothelial cell count (measured by Konan specular microscope) at 3 months
Full Information
NCT ID
NCT00972621
First Posted
September 3, 2009
Last Updated
February 21, 2018
Sponsor
Abbott Medical Optics
1. Study Identification
Unique Protocol Identification Number
NCT00972621
Brief Title
Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Official Title
Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitrax II
Arm Type
Experimental
Arm Description
Investigational dispersive viscoelastic
Arm Title
Viscoat
Arm Type
Active Comparator
Arm Description
Marketed control dispersive viscoelastic
Intervention Type
Device
Intervention Name(s)
Vitrax II
Intervention Description
Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
Intervention Type
Device
Intervention Name(s)
Viscoat
Intervention Description
Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..
Primary Outcome Measure Information:
Title
Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
Description
Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
Postoperative Mean Endothelial Cell Count
Description
mean endothelial cell count (measured by Konan specular microscope) at 3 months
Time Frame
3 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AMO Clinical Research Call Center for Trial Locations
City
Santa Ana
State/Province
California
ZIP/Postal Code
92799
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of a New Viscoelastic for Cataract Surgery
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