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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758940
Recruitment Status : Withdrawn (Primary Investigator resigned from Hospital)
First Posted : September 25, 2008
Last Update Posted : May 12, 2015
Information provided by:
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Visual Outcomes Device: Acrysof ReSTOR multifocal IOL Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens

Arm Intervention/treatment
Experimental: 1
Acrysof ReSTOR multifocal IOL
Device: Acrysof ReSTOR multifocal IOL
Implanted into the study eye following cataract extraction surgery

Primary Outcome Measures :
  1. Near,intermediate,distance visual acuity [ Time Frame: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery ]

Secondary Outcome Measures :
  1. contrast sensitivity [ Time Frame: 6 month after 2nd eye surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758940

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United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

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Responsible Party: Ricky Ho, RA Manager, Alcon Research Ltd. Identifier: NCT00758940     History of Changes
Other Study ID Numbers: HK-Restor-YIU-01
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: January 2010

Keywords provided by Alcon Research:
of visual
with the Acrysof ReSTOR
multifocal IOL