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NCT00759096 Clinical Trial

Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Visual Acuity Clinical Trial

Official title:
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00759096
Other study ID # MS-06-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date July 2008

Study information
Verified date January 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - =21 years of either gender or any race - Potential post-op VA 20/20 - Pre-op astigmatism = 1.0D - Able to sign the informed consent - Able to complete all required postoperative visits - Planned cataract removal by phaco - Clear intraocular media other than cataract Exclusion Criteria: - Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture - Any corneal pathology and previous corneal refractive surgery - Patients with unrealistic expectations in anticipated post-op VA - Happy to wear glasses - Occupational night driver

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• RESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery

Locations
Country Name City State
United States Alcon Call Center Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Near Uncorrected Visual Acuity(UCVA Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity. 6 months after surgery of 2nd eye
Secondary Contrast Sensitivity 6 months after sugery of the 2nd eye
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