AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tecnis MF
ReSTOR
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
Eligibility Criteria
Inclusion Criteria:
- Age 18 or greater
- Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Normal OCT of the macula
- No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
- No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- Amblyopia or strabismus
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
- Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Sites / Locations
- Sansum- Santa Barbara medical foundation Clinic
- Katzen Eye Care & Laser CenterRecruiting
- The Center for Excellence in Eye CareRecruiting
- Jackson Eye, SCRecruiting
- Eye Surgeons of IndianaRecruiting
- Cleveland Eye ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Tecnis MF
ReSTOR
Arm Description
Outcomes
Primary Outcome Measures
Refraction
Distance Visual Acuities
Near Visual Acuities
Intermediate Acuities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01278420
Brief Title
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Official Title
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Detailed Description
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tecnis MF
Arm Type
Other
Arm Title
ReSTOR
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Tecnis MF
Intervention Description
30 subjects will be implanted with the Tecnis MF
Intervention Type
Device
Intervention Name(s)
ReSTOR
Intervention Description
30 subjects will be implanted with ReSTOR
Primary Outcome Measure Information:
Title
Refraction
Time Frame
1 year
Title
Distance Visual Acuities
Time Frame
1 year
Title
Near Visual Acuities
Time Frame
1 year
Title
Intermediate Acuities
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or greater
Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
Clear intraocular media other than cataract
Normal OCT of the macula
No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
Use of systemic or ocular medications that may affect vision
Uncontrolled systemic or ocular disease
History of ocular trauma
History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
Amblyopia or strabismus
Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Piel
Phone
951-653-5566
Email
j.piel@imedsonline.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
The Center for Excellence in Eye Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitch Jackson, MD
Organizational Affiliation
Jackson Eye
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry Katzen, MD
Organizational Affiliation
Katzen Eye Care & Laser Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Waltz, MD
Organizational Affiliation
Eye Surgeons of Indiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shamik Bafna, MD
Organizational Affiliation
Clevland Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum- Santa Barbara medical foundation Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Katzen Eye Care & Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Katzen, MD
Facility Name
The Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Facility Name
Jackson Eye, SC
City
Lake Villa,
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitch Jackson, MD
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Waltz, MD
Facility Name
Cleveland Eye Clinic
City
Breckville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamik Bafna, MD
12. IPD Sharing Statement
Learn more about this trial
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
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