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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT02521766
Eligibility Criteria:
Inclusion Criteria:
* Must be able to understand and provide informed consent
* Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration
* Planned bilateral removal of visually significant bilateral cataracts
* Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes
* Preoperative bilateral BCDVA of 20/40 or worse
* Both eyes must have corneal astigmatism ≤ 1.50 diopter (D)
* Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study
* Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation
* History of any intraocular or corneal surgery in either eye (including refractive)
* History of any clinically significant retinal pathology or ocular diagnosis in either eye
* History of any ocular conditions which could affect the stability of the IOL
* Uncontrolled glaucoma in either eye
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02521766
Study Brief:
Protocol Section:
NCT02521766