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 26, 2014
Last verified: February 2014

October 19, 2009
February 26, 2014
October 2009
February 2012   (final data collection date for primary outcome measure)
Frequency of spectacle wear [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999492 on ClinicalTrials.gov Archive Site
Frequency and degree of visual symptoms [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataracts
Device: Tecnis® Multifocal (TMF)
Aspheric, diffractive multifocal intraocular lenses
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00999492
TMF-09-001
No
Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC
Mark Packer, MD, FACS
Not Provided
Not Provided
Drs. Fine, Hoffman and Packer, LLC
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP