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

This study is currently recruiting participants.
Verified June 2012 by Innovative Medical
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01278420
First received: August 27, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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
Cataract
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
ReSTOR Device: ReSTOR
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278420

Contacts
Contact: Jenna Piel 951-653-5566 j.piel@imedsonline.com

Locations
United States, California
Sansum- Santa Barbara medical foundation Clinic Active, not recruiting
Santa Barbara, California, United States, 93101
United States, Florida
Katzen Eye Care & Laser Center Recruiting
Boynton Beach, Florida, United States, 33426
Principal Investigator: Larry Katzen, MD         
The Center for Excellence in Eye Care Recruiting
Miami, Florida, United States, 33176
Principal Investigator: William Trattler, MD         
United States, Illinois
Jackson Eye, SC Recruiting
Lake Villa,, Illinois, United States, 60046
Principal Investigator: Mitch Jackson, MD         
United States, Indiana
Eye Surgeons of Indiana Recruiting
Indianapolis, Indiana, United States, 46256
Principal Investigator: Kevin Waltz, MD         
United States, Ohio
Cleveland Eye Clinic Recruiting
Breckville, Ohio, United States, 44141
Principal Investigator: Shamik Bafna, MD         
Sponsors and Collaborators
Innovative Medical
Investigators
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

No publications provided

Responsible Party: William Trattler, The Center for Excellence in Eye Care
ClinicalTrials.gov 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:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014