Clinical Evaluation of a New Viscoelastic for Cataract Surgery

February 21, 2018 updated by: Abbott Medical Optics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Ana, California, United States, 92799
        • AMO Clinical Research Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Mean Endothelial Cell Count
Time Frame: 3 months postoperative
mean endothelial cell count (measured by Konan specular microscope) at 3 months
3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 4, 2009

First Posted (Estimate)

September 7, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSCO-106-DISP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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