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This study has been withdrawn prior to enrollment.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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014