Contralateral ReSTOR / Monofocal or Phakic Eye - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00731640

Purpose

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Condition	Intervention	Phase
Cataracts	Device: ReSTOR	Phase IV

MedlinePlus related topics: Cataract

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive IOL in One Eye and a Contralateral Monofocal IOL or Phakic Eye

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Secondary Outcome Measures:

Contrast Sensitivity, Patient Survey [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	June 2007
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Monofocal: Active Comparator Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal IOL (unspecified) in other eye	Device: ReSTOR AcrySof ReSTOR +4 IOL unilaterally implanted
Phakic: Active Comparator Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending	Device: ReSTOR AcrySof ReSTOR +4 IOL unilaterally implanted

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731640

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon Research ( Rick Potvin/Director - Global Scientific Market Affairs )
Study ID Numbers:	M07-012
Study First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731640
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

AcrySof ReSTOR Multifocal IOL

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009