Cataract Extraction Clinical Trial
Official title:
Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
NCT number | NCT00466908 |
Other study ID # | MRC-07-001 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | August 2007 |
Verified date | October 2010 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master 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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Storm Eye Institute, Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
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