Evaluation of the Aspheric ReSTOR Intraocular Lens (IOL) After Routine Cataract Extraction

Completed

Conditions studied: Cataract Extraction, Refractive Surgery

In brief

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 historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal IOL.

Key facts

Study ID

NCT00565695

Run by

Medical University of South Carolina

People needed

20

Starts

2007-10-01

Expected to finish

2008-09-01

Last updated by the study team

2010-10-04

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
• 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.

You may not qualify if…

• 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
• Microphthalmus or macrophthalmus
• Optic nerve atrophy
• Macular degeneration (with anticipated best postoperative visual acuity less than 20/30)
• Advanced glaucomatous damage, etc.
• 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.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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