Clareon PanOptix Pro vs. Clareon PanOptix - Study B

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

• CPO Pro IOL (Device), also known as Clareon PanOptix Pro Trifocal IOL, Model PAYWT0: Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity. The Clareon™ PanOptix™ Pro Trifocal IOL is designed to enhance distance image quality by reducing chromatic aberration.
• CPO IOL (Device), also known as Clareon PanOptix, Model CNWTT0: Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
• Cataract Surgery (Procedure): Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL

Primary outcomes

• Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [Month 2 postoperative]: Visual Acuity (VA) was assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA was measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.

Sex: All, ages: 22 Years to any

Key Inclusion Criteria:

* Understand and sign an ethics committee-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
* Other protocol-defined exclusion criteria may apply.

Participant flow

Outcome results

• Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) (Primary), Mean, logMAR: CPO Pro IOL -0.016 +/- 0.1035; CPO IOL 0.010 +/- 0.0905

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent to study exit, approximately 6 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all eyes with attempted implantation (successful or aborted after contact with the eye).

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2025-03-18)
• Statistical Analysis Plan (PDF, 2024-10-04)

• Principal Clinical Trial Lead, Study director, Alcon Research, LLC