Clinical Evaluation of a New Viscoelastic for Cataract Surgery
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 7, 2009
CompletedStudy Start
First participant enrolled
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2010
CompletedResults Posted
Study results publicly available
February 22, 2012
CompletedFebruary 11, 2025
February 1, 2025
1.2 years
September 3, 2009
January 18, 2012
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months postoperative
Secondary Outcomes (1)
Postoperative Mean Endothelial Cell Count
3 months postoperative
Study Arms (2)
Vitrax II
EXPERIMENTALInvestigational dispersive viscoelastic
Viscoat
ACTIVE COMPARATORMarketed control dispersive viscoelastic
Interventions
Eligibility Criteria
You may qualify if:
- Otherwise healthy eye with no pathology other than the presence of cataract
- Visual potential of 20/40 or better
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, 92799, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kendra Hileman, Ph.D., Head, Clinical Research & Development
- Organization
- Abbott Medical Optics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 7, 2009
Study Start
September 30, 2009
Primary Completion
November 30, 2010
Study Completion
November 30, 2010
Last Updated
February 11, 2025
Results First Posted
February 22, 2012
Record last verified: 2025-02