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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:October 2009
End Date:February 2012

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Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront

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.


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
We found this trial at
1
site
Eugene, Oregon 97401
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Eugene, OR
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