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

Sponsor
Mark Packer, MD, FACS (Other)
Overall Status
Completed
CT.gov ID
NCT01275118
Collaborator
Abbott Medical Optics (Industry)
26
Enrollment
1
Location
9
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Tecnis Multifocal IOL
  • Device: crystalens Accommodating IOL
 Phase 4

Study Design

Study Type:
Interventional
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 :
Dec 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Visual function [3 months postoperatively]

Secondary Outcome Measures

  1. Use of spectacle correction and vision-related quality of life [3 months postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Packer, MD, FACS, Sponsor-Investigator, Drs. Fine, Hoffman and Packer, LLC
ClinicalTrials.gov Identifier:
NCT01275118
Other Study ID Numbers:
  • TMF-09-002 Rev.5
First Posted:
Jan 12, 2011
Last Update Posted:
Feb 28, 2014
Last Verified:
Feb 1, 2014
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Feb 28, 2014