Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Completed

• Conditions: Cataract
• Interventions: Device: Aspheric Acrysof ReSTOR intraocular lens

• Registration Number: NCT00720005
• Lead Sponsor: Medical University of South Carolina

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspheric Acrysof ResTOR Lens	Aspheric Acrysof ReSTOR intraocular lens	Implantation of Aspheric Acrysof ResTOR

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Storm Eye Institute, Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States