About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
LPYWT0
DeviceInvestigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
PXYWT0
DeviceCommercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
Cataract Surgery
Procedure/SurgeryRemoval of the cataractous lens by phacoemulsification followed by implantation of the IOL
Treatment groups
Trial outcomes
Primary outcomes
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual Acuity will be assessed using letter charts under well-lit (photopic) conditions with correction in place at a distance of 4 meters from the subject. BCDVA will be recorded in logarithm minimum angle of resolution (logMAR) where 0.0 logMAR is equivalent to 20/20 Snellen, or normal distance eyesight, and negative logMAR values represent better-than-normal distance eyesight.
Sponsors and contacts
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