Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

NCT01061918 | Completed Phase 4

• 1 other identifier: Tecnis MF/Restor
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.

Conditions

Cataract

Keywords

Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.

Outcome Measures

Primary Outcomes (2)

• Refraction

  1 year

• Distance Visual Acuities

  1 year

Study Arms (2)

Tecnis MF

ACTIVE COMPARATOR

Device: Tecnis MF

ReSTOR

ACTIVE COMPARATOR

Device: ReSTOR

Interventions

Tecnis MF DEVICE

20 patients in the Tecnis MF group.

Tecnis MF

ReSTOR DEVICE

20 patients in the ReSTOR group.

ReSTOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
• Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
• Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40
• Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
• Preoperative corneal astigmatism of 1.0 D or less
• Clear intraocular media other than cataract
• 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
• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
• Subjects with diabetes mellitus
• Uncontrolled systemic or ocular disease
• History of ocular trauma or prior ocular surgery
• 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 20/30 or worse
• Subjects who may be expected to require retinal laser treatment or other surgical intervention
• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
• Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
• Requiring an intraocular lens \<15.0 or \>26.0 diopters

Sponsors & Collaborators

• Innovative Medical: lead

Study Sites (2)

William Trattler

Miami, Florida, 33176, United States

Location

William Lahners

Sarasota, Florida, 34239, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 17, 2011

Record last verified: 2011-02

Locations

US (2)