Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01215045
Collaborator
(none)
17
1
11
1.5

Study Details

Study Description

Brief Summary

Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.

Condition or Disease Intervention/Treatment Phase
  • Device: AcrySof ReSTOR Aspheric +4

Study Design

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
ReSTOR +4

AcrySof ReSTOR Aspheric +4

Device: AcrySof ReSTOR Aspheric +4
Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [6 months]

Secondary Outcome Measures

  1. Contrast sensitivity, patient survey [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Diagnosed with cataracts
Exclusion Criteria:
  • Preexisting conditions confounding results; > 1 Diopter preoperative astigmatism

Contacts and Locations

Locations

Site City State Country Postal Code
1 Contact Alcon Call Center for Trial Locations Fort Worth Texas United States 76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01215045
Other Study ID Numbers:
  • M07-004
First Posted:
Oct 5, 2010
Last Update Posted:
Oct 5, 2010
Last Verified:
Oct 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2010