Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

NCT00720005 | Completed

• 1 other identifier: MRC-07-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cataract

Keywords

Cataract; cataract extraction; intraocular lens; age related

Outcome Measures

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).

  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.

  preoperatively, 1, 3, 6 month

Study Arms (1)

Aspheric Acrysof ResTOR Lens

Implantation of Aspheric Acrysof ResTOR

Device: Aspheric Acrysof ReSTOR intraocular lens

Interventions

Aspheric Acrysof ReSTOR intraocular lens DEVICE

Bilateral implantation of Aspheric Acrysof ReSTOR

Also known as: Acrysof ReSTOR

Aspheric Acrysof ResTOR Lens

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects 18 years or older who had cataract surgery.

You may qualify if:

• Subject must have an age-related cataract in both eyes.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Kerry D. Solomon, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 4, 2010

Record last verified: 2010-10

Locations

US (1)