We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00759096
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: RESTOR IOL Model SA60D3 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Study Start Date : May 2007
Primary Completion Date : July 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: Acrysof ReSTOR IOL
AcrySof ReSTOR Intraocular lens (IOL) implanted
Device: RESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery


Outcome Measures

Primary Outcome Measures :
  1. Near Uncorrected Visual Acuity(UCVA [ Time Frame: 6 months after surgery of 2nd eye ]

Secondary Outcome Measures :
  1. Contrast Sensitivity [ Time Frame: 6 months after sugery of the 2nd eye ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥21 years of either gender or any race
  • Potential post-op VA 20/20
  • Pre-op astigmatism ≤ 1.0D
  • Able to sign the informed consent
  • Able to complete all required postoperative visits
  • Planned cataract removal by phaco
  • Clear intraocular media other than cataract

Exclusion Criteria:

  • Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
  • Any corneal pathology and previous corneal refractive surgery
  • Patients with unrealistic expectations in anticipated post-op VA
  • Happy to wear glasses
  • Occupational night driver
Contacts and Locations

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): NCT00759096


Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Benny Li, Ph.D., Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00759096     History of Changes
Other Study ID Numbers: MS-06-03
First Posted: September 25, 2008    Key Record Dates
Results First Posted: February 10, 2010
Last Update Posted: February 10, 2010
Last Verified: January 2010

Keywords provided by Alcon Research:
bilateral implantation
ReSTOR Aspheric IOL
uniocular unaided distance
binocular unaided distance
intermediate visual acuity
near visual acuity