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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT01278420
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or greater
* Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
* Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
* Clear intraocular media other than cataract
* Normal OCT of the macula
* No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
* No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
* Use of systemic or ocular medications that may affect vision
* Uncontrolled systemic or ocular disease
* History of ocular trauma
* History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
* Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01278420
Study Brief:
Protocol Section:
NCT01278420