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
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: 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
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014