Clinical Evaluation of a Novel Trifocal IOL

Clinical Evaluation of a Novel Trifocal IOL

The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.

In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months.

This study is planned to be conducted in India and the Philippines.

Key Inclusion Criteria:

• The calculated power needed for the artificial lens (IOL) must be between +15.0 and +25.0 D in each eye, designed to bring subject vision as close to "0.0" (neutral) as possible, meaning they will not be strongly nearsighted or farsighted after surgery.
• Subjects must have low levels of astigmatism (misshapen cornea) in the eyes (less than 1.00 D).
• In the doctor's opinion, the subjects have the potential to achieve good vision (0.2 logMAR, which is roughly 20/32 Snellen or better) in each eye after the surgery, when wearing the best possible spectacles or contact lenses.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Clinically significant corneal diseases which may, according to the investigator's medical opinion, adversely affect visual outcomes.
• Any ocular or systemic health condition or medical issue that, in the investigator's medical opinion, could make the study results unreliable, prevent the person from finishing the study, or increase their safety risk.
• People who want to have one eye set for distance vision and the other for near vision.
• The doctor expects significant blurry vision (astigmatism) after the procedure.
• Other protocol-specified exclusion criteria may apply.