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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Device: Tecnis MF; Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tecnis MF	Device: Tecnis MF; 30 subjects will be implanted with the Tecnis MF
Other: ReSTOR	Device: ReSTOR; 30 subjects will be implanted with ReSTOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Refraction	1 year
Distance Visual Acuities	1 year
Near Visual Acuities	1 year
Intermediate Acuities	1 year

Collaborators and Investigators

• Sponsor: Innovative Medical
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TMF vs Restor MF 3D