Status:
COMPLETED
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract
Eligibility:
All Genders
40-90 years
Brief Summary
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 historic...
Detailed Description
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 historic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00720005
Start Date
September 1 2007
End Date
December 1 2008
Last Update
October 4 2010
Active Locations (1)
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1
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425