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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

September 23, 2008
January 25, 2010
May 2007
July 2008   (final data collection date for primary outcome measure)
Near Uncorrected Visual Acuity(UCVA [ Time Frame: 6 months after surgery of 2nd eye ] [ Designated as safety issue: Yes ]
Near, intermediate and distance visual acuity (uncorrected, best corrected) [ Time Frame: Before surgery; 1 week after surgery of each eye; 1 month and 6 months after surgery of 2nd eye ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00759096 on ClinicalTrials.gov Archive Site
Contrast Sensitivity [ Time Frame: 6 months after sugery of the 2nd eye ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Visual Acuity
Device: RESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery
Experimental: Acrysof ReSTOR IOL
AcrySof ReSTOR Intraocular lens (IOL) implanted
Intervention: Device: RESTOR IOL Model SA60D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
July 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759096
MS-06-03
No
Benny Li, Ph.D., Alcon Research Ltd.
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP