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

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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Tecnis Multifocal IOL; Device: crystalens Accommodating IOL

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Drs. Fine, Hoffman and Packer, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual function	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of spectacle correction and vision-related quality of life	3 months postoperatively

Collaborators and Investigators

• Sponsor: Mark Packer, MD, FACS
• Collaborators: Abbott Medical Optics
• Investigators: Principal Investigator: Mark Packer, MD, FACS, CPI, Drs. Fine, Hoffman and Packer, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (ESTIMATE): January 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TMF-09-002 Rev.5