Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront

NCT00999492 | Completed Phase 4

• 1 other identifier: TMF-09-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.

Conditions

Cataracts

Keywords

Tecnis Multifocal; Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses

Outcome Measures

Primary Outcomes (1)

• Frequency of spectacle wear

  3 months postoperatively

Secondary Outcomes (1)

• Frequency and degree of visual symptoms

  3 months postoperatively

Interventions

Tecnis® Multifocal (TMF) DEVICE

Aspheric, diffractive multifocal intraocular lenses

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Scheduled to undergo bilateral cataract or refractive lens surgery
• Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
• Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
• Preoperative regular corneal astigmatism of 2.5 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:

• Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
• Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
• Use of systemic or ocular medications that may affect visual outcomes
• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
• 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 worse than 20/30
• 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 or abnormally shaped pupils)
• Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
• Requiring an intraocular lens power \<15.0 or \>26.0 diopters

Sponsors & Collaborators

• Mark Packer, MD, FACS: lead

Study Sites (1)

Drs. Fine, Hoffman and Packer, LLC

Eugene, Oregon, 97401, 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 21, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

US (1)