Recruiting

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

Sponsor:

Innovative Medical

Code:

NCT01278420

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tecnis MF

ReSTOR

Study Details

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.

Conditions

Cataract

Study ID

NCT01278420

Start date

Sep, 2010

Status verified date

Jun, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Tecnis MF

other: ReSTOR

Interventions

Tecnis MF

30 subjects will be implanted with the Tecnis MF

ReSTOR

30 subjects will be implanted with ReSTOR

Primary outcome measure

Refraction [ Time Frame: 1 year ]
Distance Visual Acuities [ Time Frame: 1 year ]
Near Visual Acuities [ Time Frame: 1 year ]
Intermediate Acuities [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Jenna Piel

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

Locations

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

Jackson Eye, SC

Recruiting

Lake Villa,, Illinois, United States, 60046

Principal Investigator:

Mitch Jackson, MD

Eye Surgeons of Indiana

Recruiting

Indianapolis, Indiana, United States, 46256

Principal Investigator:

Kevin Waltz, MD

Cleveland Eye Clinic

Recruiting

Breckville, Ohio, United States, 44141

Principal Investigator:

Shamik Bafna, MD

More Information

Sponsor

Innovative Medical

Last update posted

Jun 14, 2012

Last verified

Jun, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovative Medical on 2012-06-14.