Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

Phase 4

Completed

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

• Registration Number: NCT01061918
• 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 intraocular lenses (IOLs) 6 months post cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
Distance Visual Acuities	1 year
Refraction	1 year

Trial Locations

Locations (2)

William Trattler; 🇺🇸 Miami, Florida, United States

William Lahners; 🇺🇸 Sarasota, Florida, United States