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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT00565695
Eligibility Criteria:
Inclusion Criteria:
* 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.
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
* 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.
* 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 within the past three months or intraocular laser surgery within one month in the operated eye.
* Other ocular surgery at the time of the cataract extraction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00565695
Study Brief:
Protocol Section:
NCT00565695