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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759096
First received: September 23, 2008
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Visual Acuity
 Device: RESTOR IOL Model SA60D3
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Near Uncorrected Visual Acuity(UCVA [ Time Frame: 6 months after surgery of 2nd eye ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Contrast Sensitivity [ Time Frame: 6 months after sugery of the 2nd eye ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acrysof ReSTOR IOL
AcrySof ReSTOR Intraocular lens (IOL) implanted
 Device: RESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759096

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

No publications provided

Responsible Party: Benny Li, Ph.D., Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00759096     History of Changes
Other Study ID Numbers: MS-06-03
Study First Received: September 23, 2008
Results First Received: September 11, 2009
Last Updated: January 25, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013