Rotational Stability of the AcrySof® Toric

October 26, 2012 updated by: Alcon Research
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Monolateral or bilateral cataracts
  • anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
  • 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
  • able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:

  • Preoperative ocular pathology
  • previous intraocular or corneal surgery
  • an increased risk for complications which could require vitreoretinal surgery
  • corneal irregularities
  • corneal opacities
  • current contact lens usage
  • uncontrolled diabetes

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Toric
Implantation with the AcrySof® Toric intraocular lens
Device: AcrySof® Toric intraocular lens
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotational Stability
Time Frame: 6 Months post-surgery
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
6 Months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Refractive Cylinder
Time Frame: 6 Months post-surgery
The refractive astigmatism 6 months post-surgery, measured in diopters.
6 Months post-surgery

Collaborators and Investigators

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

Sponsor

Alcon Research

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

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-08-001

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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