A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01166971
First received: July 19, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.


Condition Intervention Phase
Cataract
Device: ReSTOR +3
Device: Tecnis MF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Defocus Curve [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".


Enrollment: 65
Study Start Date: July 2010
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR +3
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
Device: ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
Active Comparator: Tecnis MF
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Device: Tecnis MF
Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with bilateral cataracts
  • candidate for presbyopic lens

Exclusion Criteria:

  • >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
  • pre-existing conditions that could skew the results
  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: NCT01166971

Locations
United States, Florida
The Eye Center of North Florida
Panama City, Florida, United States, 32405
United States, South Carolina
Carolina Eye Care Physicians
Charleston, South Carolina, United States, 29414
United States, Texas
Whitsett Vision Group
Houston, Texas, United States, 77055
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01166971     History of Changes
Other Study ID Numbers: M09-050
Study First Received: July 19, 2010
Results First Received: October 4, 2011
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
presbyopia
intraocular lens

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014