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
  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
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, see Learn About Clinical Studies.

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 October 20, 2014