Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00721253
First received: July 21, 2008
Last updated: March 4, 2010
Last verified: March 2010
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Purpose
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: ReSTOR Device: Tecnis Device: Acri.LISA |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.
Secondary Outcome Measures:
- Contrast Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
- Defocus Curve [ Time Frame: 6 months post-operative ] [ Designated as safety issue: No ]Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
| Enrollment: | 42 |
| Study Start Date: | July 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ReSTOR Aspheric +4
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
|
Device: ReSTOR
Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
|
|
Active Comparator: Tecnis MF
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
|
Device: Tecnis
Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
|
|
Active Comparator: Acri.LISA
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
|
Device: Acri.LISA
Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Diagnosed with cataracts
Exclusion Criteria:
- Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Contacts and Locations More Information
No publications provided
| Responsible Party: | Rick Potvin, Alcon |
| ClinicalTrials.gov Identifier: | NCT00721253 History of Changes |
| Other Study ID Numbers: | M07-002 |
| Study First Received: | July 21, 2008 |
| Results First Received: | September 18, 2009 |
| Last Updated: | March 4, 2010 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Alcon Research:
|
ReSTOR |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013