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Clinical Evaluation of a New Viscoelastic for Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00972621
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : February 22, 2012
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

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.

Condition or disease Intervention/treatment Phase
Cataract Device: Vitrax II Device: Viscoat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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..




Primary Outcome Measures :
  1. 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 :
  1. Postoperative Mean Endothelial Cell Count [ Time Frame: 3 months postoperative ]
    mean endothelial cell count (measured by Konan specular microscope) at 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, California
AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, United States, 92799
Sponsors and Collaborators
Abbott Medical Optics
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00972621    
Other Study ID Numbers: VSCO-106-DISP
First Posted: September 7, 2009    Key Record Dates
Results First Posted: February 22, 2012
Last Update Posted: February 23, 2018
Last Verified: January 2017
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases