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

Mark Packer, MD, FACS

Status and phase

Completed

Phase 4

Conditions

Cataracts

Treatments

Device: Tecnis® Multifocal (TMF)

Study type

Interventional

Funder types

Other

Identifiers

NCT00999492

TMF-09-001

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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