Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT00934804
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00934804
Study Brief:
Protocol Section:
NCT00934804