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 |
---|---|---|
|
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
- Visual Acuity [6 months]
Secondary Outcome Measures
- 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