Clinical Evaluation of a New Viscoelastic for Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00972621
First received: September 3, 2009
Last updated: March 19, 2012
Last verified: March 2012
  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 Phase
Cataract
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 IOP spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Cumulative ] [ Designated as safety issue: Yes ]
    All adverse events regardless of severity were reported. Adverse events were considered serious if they were sight or life threatening, resulted in permenant implairment of a body function or structure (i.e. of the eye) or required medical or surgical intervention to prevent further impairment.


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 adminstered 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 adminstered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov 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: March 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014