We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818116
First Posted: January 7, 2009
Last Update Posted: July 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Condition Intervention Phase
Cataracts Device: AcrySof ReSTOR Aspheric IOL Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected and Best Corrected Visual Acuities (Near and Distance) [ Time Frame: 6 Months Following Cataract Surgery ]
    Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


Enrollment: 34
Study Start Date: December 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Device: AcrySof ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
  • 50~75 years of age
  • <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

  • Patients with pre-existing conditions that could skew the results.
  • Any of conditions before and during surgery specified in the product information.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818116


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

Responsible Party: China: Ethics Committee, Alcon China
ClinicalTrials.gov Identifier: NCT00818116     History of Changes
Other Study ID Numbers: CH-08-001
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: June 30, 2010
Results First Posted: July 30, 2010
Last Update Posted: July 30, 2010
Last Verified: June 2010

Keywords provided by Alcon Research:
Cataract
visual acuity
AcrySof ReSTOR Aspheric Intraoculare Lens
Bilateral cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases