Multifocals and Accommodating/Bilateral Implantation of Different Multifocal Intraocular Lens (IOLs)

Stopped early

Conditions studied: Cataracts

In brief

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), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification. The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.

Key facts

Study ID

NCT00934960

Run by

Medical University of South Carolina

People needed

9

Starts

2009-03-01

Expected to finish

2009-10-01

Last updated by the study team

2009-11-18

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Helga Sandoval, MD — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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