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AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Innovative Medical.
Recruitment status was:  Recruiting
Information provided by:
Innovative Medical Identifier:
First received: August 27, 2010
Last updated: June 13, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Device: Tecnis MF
Device: ReSTOR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Resource links provided by NLM:

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Distance Visual Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Near Visual Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intermediate Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tecnis MF Device: Tecnis MF
30 subjects will be implanted with the Tecnis MF
30 subjects will be implanted with ReSTOR

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01278420

United States, California
Sansum- Santa Barbara medical foundation Clinic
Santa Barbara, California, United States, 93101
United States, Florida
Katzen Eye Care & Laser Center
Boynton Beach, Florida, United States, 33426
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Illinois
Jackson Eye, SC
Lake Villa,, Illinois, United States, 60046
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Ohio
Cleveland Eye Clinic
Breckville, Ohio, United States, 44141
Sponsors and Collaborators
Innovative Medical
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Principal Investigator: Mitch Jackson, MD Jackson Eye
Principal Investigator: Larry Katzen, MD Katzen Eye Care & Laser Center
Principal Investigator: Kevin Waltz, MD Eye Surgeons of Indiana
Principal Investigator: Shamik Bafna, MD Clevland Eye Clinic
  More Information

Responsible Party: William Trattler, The Center for Excellence in Eye Care Identifier: NCT01278420     History of Changes
Other Study ID Numbers: TMF vs Restor MF 3D 
Study First Received: August 27, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on January 17, 2017