Visual Function After Bilateral Implantation of AcrySof® Toric

March 4, 2010 updated by: Alcon Research
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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:

  • Bilateral cataracts
  • 40~80 years of age
  • 4 Days - 1 Week interval between a single patient's surgery
  • dilated pupil size (in dim light) ≥ 4.0 mm
  • Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
  • 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

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(within 6 months prior to first surgery)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Active Comparator: AcrySof Natural IOL
AcrySof Natural Intraocular Lens (IOL)
Device: AcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity (UCVA)
Time Frame: 6 Months after surgery
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
6 Months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire Results
Time Frame: 6 Months
Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).
6 Months

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

April 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 4, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CM-06-17

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.

Subscribe