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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT07213167
Eligibility Criteria:
Inclusion Criteria:
* Minimum 22 years of age
* Bilateral pseudophakia, at least 3 months postoperative from IOL implantation, with one of the study IOL models in at least one eye.
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
* Ability to understand and respond to a questionnaire in English
Exclusion Criteria:
* Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils.
* Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
* Uncorrected distance visual acuity worse than 20/25 in either eye
* Prior corneal refractive surgery (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes are acceptable.
* Posterior capsular opacification with grading worse than 1+
* Ocular findings that may, in the opinion of the investigator, affect vision and/or contrast sensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07213167
Study Brief:
Protocol Section:
NCT07213167