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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00934960
Eligibility Criteria:
Inclusion Criteria:
Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
* Subject must have a multifocal or an accommodating IOL implanted bilaterally.
* Age: 40 to 90 years old.
* At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
* Willing and able to comply with scheduled visit and other study procedures.
Exclusion Criteria:
Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
* Ocular pathology affecting visual acuity: 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 best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
* Keratometric astigmatism exceeding 2.00 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.
* 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 either eye.
* Other ocular surgery at the time of the cataract extraction.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT00934960
Study Brief:
Protocol Section:
NCT00934960