Presbyopia-Correcting Intraocular Lenses (IOLs)

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00963560
First received: August 19, 2009
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).


Condition Intervention Phase
Cataract
Device: ReSTOR +3
Device: Crystalens HD
Device: Crystalens AO
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:
  • Best Corrected Visual Acuity [ Time Frame: 6 Months after surgery ] [ Designated as safety issue: No ]
    Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.


Enrollment: 132
Study Start Date: August 2009
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 Lens (IOL)
Device: ReSTOR +3
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Device: Crystalens HD
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Device: Crystalens AO
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.

  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 preoperative astigmatism by Keratometry readings
  • pre-existing conditions that could skew the results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963560

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Diane Houtman, Director - Global Scientific Market Affairs Dept, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00963560     History of Changes
Other Study ID Numbers: M09-008
Study First Received: August 19, 2009
Results First Received: July 13, 2011
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
ReSTOR +3

Additional relevant MeSH terms:
Presbyopia
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on April 16, 2014