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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC
ClinicalTrials.gov Identifier:
NCT00999492
First received: October 19, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataracts
 Device: Tecnis® Multifocal (TMF)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Drs. Fine, Hoffman and Packer, LLC:

Primary Outcome Measures:
  • Frequency of spectacle wear [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and degree of visual symptoms [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tecnis® Multifocal (TMF)
    Aspheric, diffractive multifocal intraocular lenses
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999492

Locations
United States, Oregon
Drs. Fine, Hoffman and Packer, LLC
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Mark Packer, MD, FACS
  More Information

No publications provided

Responsible Party: Mark Packer, MD, FACS, Sponsor-Investigator, Drs. Fine, Hoffman and Packer, LLC
ClinicalTrials.gov Identifier: NCT00999492     History of Changes
Obsolete Identifiers: NCT01061892
Other Study ID Numbers: TMF-09-001
Study First Received: October 19, 2009
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Drs. Fine, Hoffman and Packer, LLC:
Tecnis Multifocal
Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013