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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tecnis® Multifocal (TMF)

Aspheric, diffractive multifocal intraocular lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No