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

Phase 4

• Conditions: Cataract
• Interventions: Device: Tecnis MF; Device: ReSTOR

• Registration Number: NCT01278420
• Lead Sponsor: Innovative Medical

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.

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 Timeline

• Study First Submitted: 2010-08-27
• Study Start: 2010-09
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tecnis MF	Tecnis MF	-
ReSTOR	ReSTOR	-

Primary Outcome Measures

Name	Time	Method
Intermediate Acuities	1 year
Refraction	1 year
Distance Visual Acuities	1 year
Near Visual Acuities	1 year

Trial Locations

Locations (6)

Sansum- Santa Barbara medical foundation Clinic; 🇺🇸 Santa Barbara, California, United States

Katzen Eye Care & Laser Center; 🇺🇸 Boynton Beach, Florida, United States

The Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Cleveland Eye Clinic; 🇺🇸 Breckville, Ohio, United States

Eye Surgeons of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Jackson Eye, SC; 🇺🇸 Lake Villa,, Illinois, United States