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

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tecnis® Multifocal (TMF)
Sponsored by
Mark Packer, MD, FACS
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Tecnis Multifocal, Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drs. Fine, Hoffman and Packer, LLC

Outcomes

Primary Outcome Measures

Frequency of spectacle wear

Secondary Outcome Measures

Frequency and degree of visual symptoms

Full Information

First Posted
October 19, 2009
Last Updated
February 26, 2014
Sponsor
Mark Packer, MD, FACS
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1. Study Identification

Unique Protocol Identification Number
NCT00999492
Brief Title
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront
Official Title
Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Packer, MD, FACS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Tecnis Multifocal, Patients scheduled for cataract or lens replacement surgery with implantation of multifocal intraocular lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Tecnis® Multifocal (TMF)
Intervention Description
Aspheric, diffractive multifocal intraocular lenses
Primary Outcome Measure Information:
Title
Frequency of spectacle wear
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Frequency and degree of visual symptoms
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Drs. Fine, Hoffman and Packer, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

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

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