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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01602068
Eligibility Criteria:
Inclusion Criteria:
* Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
* Male or female 18 years or older
* Receive, understand, and sign a copy of the written informed consent form
* Be able to return for all study visits and willing to comply with all study-related instructions
Exclusion Criteria:
* Subjects not meeting the inclusion criteria
* Subjects being implanted with a multifocal IOL
* Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
* Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
* Scheduled for surgery in the fellow eye within the study period
* Have anterior chamber inflammation as measured by slit lamp examination at baseline. Anterior chamber cell and/or flare grade \> 0
* Have used any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to baseline visit
* Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications
* Be known corticosteroid intraocular pressure responder in either eye
* Have used topical corticosteroid or NSAID treatment in either eye ≤ 48 hours prior to baseline visit
* Systemic administration of corticosteroid within the past 14 days prior to baseline visit
* Have received intravitreal, sub-Tenon's, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit
* Have open wounds/ skin disease on the forehead area where the iontophoresis return electrode will be applied
* Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
* Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding the placement of the iontophoresis applicator
* Have significant Fuch's Corneal Dystrophy
* Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
* Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin
* Have optic neuritis of any origin
* Have clinically suspected or confirmed central nervous system or ocular lymphoma
* Have active hyphema, pars planitis, choroiditis, Behçet's disease, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
* Have severe/serious ocular pathology or medical condition which may preclude study completion
* History of HIV/AIDS
* Have pacemaker and/or any other electrical sensitive support system
* Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
* Have participated in another investigational device or drug study within 30 days of baseline visit
* Have already participated in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01602068
Study Brief:
Protocol Section:
NCT01602068