Status:
COMPLETED
Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract Extraction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estim...
Eligibility Criteria
Inclusion
- Subject must have an age-related cataract in both eyes.
- 18 years of age or older.
- Patient must desire cataract extraction.
- Expected maximum of 4 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: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Keratometric astigmatism exceeding 2.0 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 :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00366587
Start Date
February 1 2006
End Date
August 1 2007
Last Update
June 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425