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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

This study has been withdrawn prior to enrollment.
(Primary Investigator resigned from Hospital)
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758940
First received: September 23, 2008
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

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
Arms Assigned Interventions
Experimental: 1
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

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: Ricky Ho, RA Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00758940     History of Changes
Other Study ID Numbers: HK-Restor-YIU-01
Study First Received: September 23, 2008
Last Updated: January 22, 2010
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 May 23, 2013