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

Phase 4

Completed

• Conditions: Cataracts

• Registration Number: NCT00999492
• Lead Sponsor: Mark Packer, MD, FACS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of spectacle wear	3 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Frequency and degree of visual symptoms	3 months postoperatively

Trial Locations

Locations (1)

Drs. Fine, Hoffman and Packer, LLC; 🇺🇸 Eugene, Oregon, United States