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

NCT01275118 | Completed Phase 4

• 1 other identifier: TMF-09-002 Rev.5
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Visual function

  3 months postoperatively

Secondary Outcomes (1)

• Use of spectacle correction and vision-related quality of life

  3 months postoperatively

Interventions

Tecnis Multifocal IOL DEVICE

Presbyopia correcting IOL

crystalens Accommodating IOL DEVICE

Presbyopia correcting IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mark Packer, MD, FACS: lead
• Abbott Medical Optics: collaborator

Study Sites (1)

Drs. Fine, Hoffman and Packer, LLC

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Mark Packer, MD, FACS, CPI

  Drs. Fine, Hoffman and Packer, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

US (1)