NCT00758940

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

May 12, 2015

Status Verified

January 1, 2010

First QC Date

September 23, 2008

Last Update Submit

May 8, 2015

Conditions

Visual Outcomes

Keywords

Clinicalassessmentof visualfunctionwith the Acrysof ReSTORmultifocal IOL

Outcome Measures

Primary Outcomes (1)

  • Near,intermediate,distance visual acuity

    pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery

Secondary Outcomes (1)

  • contrast sensitivity

    6 month after 2nd eye surgery

Study Arms (1)

1

EXPERIMENTAL

Acrysof ReSTOR multifocal IOL

Device: Acrysof ReSTOR multifocal IOL

Interventions

Acrysof ReSTOR multifocal IOLDEVICE

Implanted into the study eye following cataract extraction surgery

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Last Updated

May 12, 2015

Record last verified: 2010-01

Locations

US(1)