Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive Surgery

Stopped early · Not applicable

Conditions studied: Cataracts

In brief

The purpose of this study is to determine the accuracy of the Galilei corneal analyzer to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.

Key facts

Study ID

NCT00934804

Run by

Medical University of South Carolina

People needed

7

Starts

2009-06-01

Expected to finish

2009-10-01

Last updated by the study team

2018-07-23

Who can join

Age: 40 and older, up to 80. 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 undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction.
• Age: 40 to 80 years old.
• Subjects must have undergone cataract extraction at least 4 weeks prior to enrollment in this trial.
• Willing and able to comply with scheduled visits 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.
• 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.
• 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. 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 (other than cataract extraction) within the past three months or intraocular laser surgery within one month in the operated eye.

Where it is running

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

Full record on ClinicalTrials.gov

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