Clinical Evaluation of a New Viscoelastic for Cataract Surgery

This study has been completed.
Information provided by (Responsible Party):
Abbott Medical Optics Identifier:
First received: September 3, 2009
Last updated: September 30, 2015
Last verified: September 2015
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 Phase
Device: Vitrax II
Device: Viscoat
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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..


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00972621

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

No publications provided

Responsible Party: Abbott Medical Optics Identifier: NCT00972621     History of Changes
Other Study ID Numbers: VSCO-106-DISP
Study First Received: September 3, 2009
Results First Received: January 18, 2012
Last Updated: September 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Lens Diseases processed this record on November 27, 2015