Status:
TERMINATED
Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive Surgery
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataracts
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 cor...
Detailed Description
The accuracy of IOL calculation is important for the visual outcome of patients undergoing cataract extraction and IOL implantation. Different formulas such as Holladay I, HofferQ, SRKT have been used...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00934804
Start Date
June 1 2009
End Date
October 1 2009
Last Update
July 23 2018
Active Locations (1)
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1
Helga Sandoval, MD
Charleston, South Carolina, United States, 29425