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Clinical Evaluation of a New Viscoelastic for Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972621
First Posted: September 7, 2009
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Medical Optics
  Purpose
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.

Condition Intervention
Cataract Device: Vitrax II Device: Viscoat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Postoperative Mean Endothelial Cell Count [ Time Frame: 3 months postoperative ]
    mean endothelial cell count (measured by Konan specular microscope) at 3 months


Enrollment: 400
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Viscoat
Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, United States, 92799
Sponsors and Collaborators
Abbott Medical Optics
  More Information

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00972621     History of Changes
Other Study ID Numbers: VSCO-106-DISP
First Submitted: September 3, 2009
First Posted: September 7, 2009
Results First Submitted: January 18, 2012
Results First Posted: February 22, 2012
Last Update Posted: March 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases