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OpenTrials
Completed

NCT Number: NCT00999492

Selection of Aspheric Diffractive Multifocal Intraocular Lens (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Drs. Fine, Hoffman and Packer, LLC

Eugene, Oregon, 97401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tecnis® Multifocal (TMF)

Device

Aspheric, diffractive multifocal intraocular lenses

Primary outcomes

  1. Frequency of spectacle wear

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Frequency and degree of visual symptoms

    Time frame: 3 months postoperatively

Sponsors and collaborators

Lead sponsor

Mark Packer, MD, FACS

Other

Registry information

Official study title

Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2009
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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