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Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL

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ClinicalTrials.gov Identifier: NCT01275118
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : February 28, 2014
Sponsor:
Collaborator:
Abbott Medical Optics
Information provided by (Responsible Party):
Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC

Brief Summary:
Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL

Condition or disease Intervention/treatment Phase
Cataract Device: Tecnis Multifocal IOL Device: crystalens Accommodating IOL Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence With Bilateral Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens AO (CAO) Intraocular Lens
Study Start Date : December 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources


Intervention Details:
    Device: Tecnis Multifocal IOL
    Presbyopia correcting IOL
    Device: crystalens Accommodating IOL
    Presbyopia correcting IOL


Primary Outcome Measures :
  1. Visual function [ Time Frame: 3 months postoperatively ]

Secondary Outcome Measures :
  1. Use of spectacle correction and vision-related quality of life [ Time Frame: 3 months postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
  • Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
  • Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
  • Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

  • Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
  • 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
  • History of ocular surgery other than that required for inclusion in this study
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275118


Locations
United States, Oregon
Drs. Fine, Hoffman and Packer, LLC
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Mark Packer, MD, FACS
Abbott Medical Optics
Investigators
Principal Investigator: Mark Packer, MD, FACS, CPI Drs. Fine, Hoffman and Packer, LLC

Responsible Party: Mark Packer, MD, FACS, Sponsor-Investigator, Drs. Fine, Hoffman and Packer, LLC
ClinicalTrials.gov Identifier: NCT01275118     History of Changes
Other Study ID Numbers: TMF-09-002 Rev.5
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases