Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00720005

Purpose

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

Condition	Intervention	Phase
Cataract	Device: Aspheric Acrysof ReSTOR intraocular lens	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance). [ Time Frame: Preoperatively, 1, 3 and 6 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire. [ Time Frame: preoperatively, 1, 3, 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Implantation of Aspheric Acrysof ResTOR	Device: Aspheric Acrysof ReSTOR intraocular lens Bilateral implantation of Aspheric Acrysof ReSTOR

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have an age-related cataract in both eyes.
40 years of age or older.
Patient must desire cataract extraction.
Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

Preoperative ocular pathology potentially affecting visual acuity.
Keratometric astigmatism exceeding 1.50 diopters.
Planned postoperative refraction for mono-vision.
Uncontrolled diabetes.
Use of any systemic or topical drug known to interfere with visual performance.
Contact lens use during the active treatment portion of the trial.
Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
Other ocular surgery at the time of the cataract extraction.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720005

Locations

United States, South Carolina
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Storm Eye Institute - Medical University of South Carolina ( Kerry D Solomon, MD )
Study ID Numbers:	MRC-07-002
Study First Received:	July 18, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00720005 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Cataract
cataract extraction
intraocular lens
age related

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 September 09, 2009