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CompletedNCT00720005Updated Oct 4, 2010

Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

An observational study in Cataract, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-10-04.

Sponsored by Medical University of South Carolina · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
20
Ages
40 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

Read the detailed description

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract
  • cataract extraction
  • intraocular lens
  • age related
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 20 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects 18 years or older who had cataract surgery.

Inclusion criteria

  • Subject must have an age-related cataract in both eyes.
  • 40 years of age or older.
  • Patient must desire cataract extraction.
  • Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
  • Willing and able to comply with scheduled visits and other study procedures

Exclusion criteria

Exclusion Criteria:

  • Preoperative ocular pathology potentially affecting visual acuity.
  • Keratometric astigmatism exceeding 1.50 diopters.
  • Planned postoperative refraction for mono-vision.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
  • Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
  • Other ocular surgery at the time of the cataract extraction.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
20 participants (actual)

Groups and cohorts

  • Aspheric Acrysof ResTOR Lens

    Implantation of Aspheric Acrysof ResTOR

    Device: Aspheric Acrysof ReSTOR intraocular lens

Interventions

  • DeviceAspheric Acrysof ReSTOR intraocular lens

    Bilateral implantation of Aspheric Acrysof ReSTOR

    Also known as: Acrysof ReSTOR

06

What researchers measure

Primary outcomes

  1. ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).

    Time frame: Preoperatively, 1, 3 and 6 months postoperatively

Secondary outcomes

  1. pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.

    Time frame: preoperatively, 1, 3, 6 month

07

Study locations

1 site
  • Storm Eye Institute, Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00720005
Lead sponsor
Medical University of South Carolina
First posted
Jul 22, 2008
Start date
Sep 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Oct 4, 2010

Study contacts

Kerry D. Solomon, MD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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