Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Cataract

Treatments: Device: Aspheric Acrysof ReSTOR intraocular lens

Study type: Observational

Funder types: Other

Identifiers

NCT00720005

MRC-07-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

20 participants in 1 patient group

Aspheric Acrysof ResTOR Lens

Description:

Implantation of Aspheric Acrysof ResTOR

Treatment:

Device: Aspheric Acrysof ReSTOR intraocular lens