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Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: January 6, 2009
Last updated: June 30, 2010
Last verified: June 2010
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
Device: AcrySof ReSTOR Aspheric IOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.


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

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
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Please refer to this study by its identifier: NCT00818116

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 Identifier: NCT00818116     History of Changes
Other Study ID Numbers: CH-08-001
Study First Received: January 6, 2009
Results First Received: June 30, 2010
Last Updated: June 30, 2010

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

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on May 22, 2017