Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Abbott Medical Optics
Information provided by (Responsible Party):
Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC
ClinicalTrials.gov Identifier:
NCT01275118
First received: January 10, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Cataract
Device: Tecnis Multifocal IOL
Device: crystalens Accommodating IOL
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: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Visual function [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of spectacle correction and vision-related quality of life [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tecnis Multifocal IOL
    Presbyopia correcting IOL
    Device: crystalens Accommodating IOL
    Presbyopia correcting IOL
  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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 10, 2011
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014