Back to resultsA Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReSTOR +3
Tecnis MF
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring presbyopia, intraocular lens
Eligibility Criteria
Inclusion Criteria:
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
Exclusion Criteria:
- >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
- pre-existing conditions that could skew the results
Sites / Locations
- The Eye Center of North Florida
- Carolina Eye Care Physicians
- Whitsett Vision Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ReSTOR +3
Tecnis MF
Arm Description
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Outcomes
Primary Outcome Measures
Defocus Curve
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01166971
Brief Title
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
Official Title
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
presbyopia, intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR +3
Arm Type
Experimental
Arm Description
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
Arm Title
Tecnis MF
Arm Type
Active Comparator
Arm Description
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Intervention Type
Device
Intervention Name(s)
ReSTOR +3
Intervention Description
Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
Intervention Type
Device
Intervention Name(s)
Tecnis MF
Intervention Description
Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction
Primary Outcome Measure Information:
Title
Defocus Curve
Description
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with bilateral cataracts
candidate for presbyopic lens
Exclusion Criteria:
>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
pre-existing conditions that could skew the results
Facility Information:
Facility Name
The Eye Center of North Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Carolina Eye Care Physicians
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)
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