Status:
TERMINATED
Multifocals and Accommodating/Bilateral Implantation of Different Multifocal Intraocular Lens (IOLs)
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataracts
Eligibility:
All Genders
40-90 years
Brief Summary
The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), r...
Detailed Description
STUDY DESIGN: This is a prospective, non-randomized, unmasked pilot study. 1. SETTING: Storm Eye Institute, Medical University of South Carolina, Charleston, SC 2. SUBJECTS A total of 50 patien...
Eligibility Criteria
Inclusion
- Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- Subject must have a multifocal or an accommodating IOL implanted bilaterally.
- Age: 40 to 90 years old.
- At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
- Willing and able to comply with scheduled visit and other study procedures.
Exclusion
- Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- Ocular pathology affecting visual acuity: 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, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration (with best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Keratometric astigmatism exceeding 2.00 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.
- 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 either eye.
- Other ocular surgery at the time of the cataract extraction.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00934960
Start Date
March 1 2009
End Date
October 1 2009
Last Update
November 18 2009
Active Locations (1)
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1
Helga Sandoval, MD
Charleston, South Carolina, United States, 29425