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

Sponsor
Innovative Medical (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01278420
Collaborator
(none)
60
Enrollment
6
Locations
2
Arms
27
Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tecnis MF
  • Device: ReSTOR
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Refraction [1 year]

  2. Distance Visual Acuities [1 year]

  3. Near Visual Acuities [1 year]

  4. Intermediate Acuities [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes 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

Locations

Site City State Country Postal Code
1 Sansum- Santa Barbara medical foundation Clinic Santa Barbara California United States 93101
2 Katzen Eye Care & Laser Center Boynton Beach Florida United States 33426
3 The Center for Excellence in Eye Care Miami Florida United States 33176
4 Jackson Eye, SC Lake Villa, Illinois United States 60046
5 Eye Surgeons of Indiana Indianapolis Indiana United States 46256
6 Cleveland Eye Clinic Breckville Ohio United States 44141

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01278420
Other Study ID Numbers:
  • TMF vs Restor MF 3D
First Posted:
Jan 17, 2011
Last Update Posted:
Jun 14, 2012
Last Verified:
Jun 1, 2012
Keywords provided by , ,
Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jun 14, 2012