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Surgeon Experience ReSTOR A +4
This study has been completed.
First Received: August 8, 2008   Last Updated: August 11, 2008   History of Changes
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00733512
  Purpose

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the USA.


Condition Intervention Phase
Cataract
Device: ReSTOR
Phase IV

MedlinePlus related topics: Cataract Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Retrospective
Official Title: Surgeon Experience ReSTOR +4

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 week to 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Contrast sensitivity [ Time Frame: 1 week to 10 months ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: June 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ReSTOR
AcrySof ReSTOR Aspheric +4 IOL
Device: ReSTOR
Patients received AcrySof ReSTOR Aspheric +4 IOL in one or both eyes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • operable cataracts; candidate for presbyopic correcting IOL

Exclusion Criteria:

  • ocular comorbidities confounding study outcomes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733512

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

No publications provided

Responsible Party: Alcon Research ( Rick Potvin/Director - Global Scientific Market Affairs Dept )
Study ID Numbers: M07-019
Study First Received: August 8, 2008
Last Updated: August 11, 2008
ClinicalTrials.gov Identifier: NCT00733512     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
ReSTOR Aspheric +4 IOL

Study placed in the following topic categories:
Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009