Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study has been completed.

First Received: September 23, 2008 No Changes Posted

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00759096

Purpose

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.

Condition	Intervention	Phase
Visual Acuity	Device: RESTOR IOL Model SA60D3	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Near, intermediate and distance visual acuity (uncorrected, best corrected) [ Time Frame: Before surgery; 1 week after surgery of each eye; 1 month and 6 months after surgery of 2nd eye ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Contrast sensitivity [ Time Frame: 6 months after sugery of the 2nd eye ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	May 2007
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Acrysof ReSTOR IOL	Device: RESTOR IOL Model SA60D3 Implanted into the study eye following cataract extraction surgery

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759096

Locations

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research Ltd. ( Benny Li, Ph.D. )
Study ID Numbers:	MS-06-03
Study First Received:	September 23, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00759096 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Alcon Research:

Visual parameters after bilateral implantation of ReSTOR Aspheric IOL
To assess uniocular and binocular unaided distance, intermediate, and near VA

ClinicalTrials.gov processed this record on September 11, 2009