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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT00999492
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Scheduled to undergo bilateral cataract or refractive lens surgery
* Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Preoperative regular corneal astigmatism of 2.5 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
* Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
* Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
* Use of systemic or ocular medications that may affect visual outcomes
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery
* 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 worse than 20/30
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
* Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
* Requiring an intraocular lens power \<15.0 or \>26.0 diopters
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00999492
Study Brief:
Protocol Section:
NCT00999492