Status:
WITHDRAWN
Depth of Focus Comparison Between Acrysof IQ and Acrysof Natural IOLs
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract
Vision
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to evaluate and compare the depth of focus and visual outcomes after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof Natural SN60AT s...
Detailed Description
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
- Patient
- Subject must have an age-related cataract in both eyes;
- Subject must be 40 years of age or older;
- Subject must desire cataract extraction;
- Expected maximum of 2 weeks and minimum of 1 week interval between the first and second eye surgeries; AND
- Subject must be willing and able to comply with scheduled visits and other study procedures.
- Patient
Exclusion
- Preoperative ocular pathology: amblyopia, shallow anterior chamber, aniridia, history of iritis, iris neovascularization or iris atrophy, uveitis, medically uncontrolled glaucoma or advanced glaucomatous damage, rubella cataract, diabetic retinopathy, macular edema, retinal detachment, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), etc.;
- Keratometric astigmatism exceeding 1.5 diopters;
- 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.
- Prior history of eye surgery;
- Other ocular surgery at the time of the cataract extraction (except limbal relaxing incisions, LRI); OR
- History of trauma.
- Surgical
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00886249
Start Date
March 1 2009
End Date
October 1 2009
Last Update
June 7 2018
Active Locations (1)
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1
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States, 29425