Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study is not yet open for participant recruitment.

Verified by Alcon Research, September 2008

First Received: September 23, 2008 Last Updated: July 1, 2009 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00758940

Purpose

An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye

Condition	Intervention	Phase
Visual Outcomes	Device: Acrysof ReSTOR multifocal IOL	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment
Official Title:	A Six-Months, Open-Labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-Ocular Lens

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Near,intermediate,distance visual acuity [ Time Frame: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

contrast sensitivity [ Time Frame: 6 month after 2nd eye surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Acrysof ReSTOR multifocal IOL	Device: Acrysof ReSTOR multifocal IOL 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:

Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int

Exclusion Criteria:

Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758940

Contacts

Contact: Alcon Call Center

1-888-451-3937

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. ( Ricky Ho, RA Manager )
Study ID Numbers:	HK-Restor-YIU-01
Study First Received:	September 23, 2008
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00758940 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Alcon Research:

Clinical
assessment
of visual

function
with the Acrysof ReSTOR
multifocal IOL

ClinicalTrials.gov processed this record on September 11, 2009