NCT01278420

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

August 27, 2010

Last Update Submit

June 13, 2012

Conditions

Cataract

Keywords

Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery

Outcome Measures

Primary Outcomes (4)

  • Refraction

    1 year

  • Distance Visual Acuities

    1 year

  • Near Visual Acuities

    1 year

  • Intermediate Acuities

    1 year

Study Arms (2)

Tecnis MF

OTHER
Device: Tecnis MF

ReSTOR

OTHER
Device: ReSTOR

Interventions

Tecnis MFDEVICE

30 subjects will be implanted with the Tecnis MF

Tecnis MF
ReSTORDEVICE

30 subjects will be implanted with ReSTOR

ReSTOR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sansum- Santa Barbara medical foundation Clinic

Santa Barbara, California, 93101, United States

ACTIVE NOT RECRUITING

Katzen Eye Care & Laser Center

Boynton Beach, Florida, 33426, United States

RECRUITING

The Center for Excellence in Eye Care

Miami, Florida, 33176, United States

RECRUITING

Jackson Eye, SC

Lake Villa, Illinois, 60046, United States

RECRUITING

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

RECRUITING

Cleveland Eye Clinic

Breckville, Ohio, 44141, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Piel

CONTACT

951-653-5566j.piel@imedsonline.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 27, 2010

First Posted

January 17, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(6)