Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

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:	NCT00710905

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 IOL Models SN6AD1 And SN6AD3.

Condition	Intervention	Phase
Cataract	Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Assessment of visual function (VF), mesopic and photopic contrast sensitivity (CS), patient quality of vision, IOL decentration and tilt, PCO. [ Time Frame: Pre-op, 1 month, 3 month and 6 month ] [ Designated as safety issue: Yes ]

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 Contralateral implantation of ReSTOR +3 in one eye, ReSTOR +4 in the other eye.	Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3 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: NCT00710905

Contacts

Contact: Myrna Bergen

1-905-826-6700 ext 2357

Myrna.bergen@alconlabs.com

Locations

Canada, British Columbia
Dr John Blaylock
Abbotsford, British Columbia, Canada, V2S 5A1
Canada, Quebec
Dr Dominique Meyer
Quebec City, Quebec, Canada, G1S 1X6

Sponsors and Collaborators

Alcon Research

Investigators

Principal Investigator:

John Blaylock

Unaffiliated

More Information

No publications provided

Responsible Party:	Alcon Canada Inc ( Ms Myrna Bergen/Phase IV Clinical Research Manager )
Study ID Numbers:	ALCONsur002.08
Study First Received:	July 3, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00710905 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alcon Research:

Cataract IOL ReSTOR Aspheric
Bilateral cataract

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