Presbyopia-Correcting Intraocular Lenses (IOLs)

July 13, 2011 updated by: Alcon Research

A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

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
        • Contact Alcon 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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with bilateral cataracts
  • candidate for presbyopic lens

Exclusion Criteria:

  • > 1 Diopter preoperative astigmatism by Keratometry readings
  • pre-existing conditions that could skew the results

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Device: ReSTOR +3
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Device: Crystalens HD
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Device: Crystalens AO
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: 6 Months after surgery
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
6 Months after 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

August 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M09-008

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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