Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

This study is not yet open for participant recruitment.

Verified by Alcon Research, August 2008

First Received: July 3, 2008 Last Updated: August 4, 2008 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00710931

Purpose

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 IOL.

Condition	Intervention	Phase
Cataract	Device: AcrySof ReSTOR Aspheric IOL model SN6AD1	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Visual acuity at distance, near and intermediate [ Time Frame: Pre-op, 1 month, 3 month and 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of visual function (VF) [ Time Frame: Pre-op, 1 month, 3 month and 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bilateral implantation of ReSTOR +3 IOL	Device: AcrySof ReSTOR Aspheric IOL model SN6AD1 Cataract implantations and multiple follow-up assessments

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens. Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by K readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710931

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Laboratories, Inc. ( Myrna Bergen )
Study ID Numbers:	ALCONsur001.08
Study First Received:	July 3, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00710931 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Bilateral Cataract
IOL
ReSTOR
Aspheric

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009