Trial Outcomes & Findings for Clareon PanOptix Pro vs. Clareon PanOptix - Study B (NCT NCT06401551)

Last Updated: 2026-02-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

71 participants

Primary outcome timeframe

Month 2 postoperative

Results posted on

2026-02-11

Participant Flow

Of the 71 randomized participants, 2 were discontinued after randomization and prior to attempted implantation. This reporting group includes all participants with attempted implantation (69). Note: One participant was implanted in one eye only (i.e., with CPO Pro IOL).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	CPO Pro IOL / CPO IOL CPO Pro IOL Model PAYWT0 implanted in one eye with CPO IOL Model CNWTT0 implanted in the other eye, as randomized. The second eye surgery occurred approximately 7-14 days after the first eye surgery. The CPO Pro IOL is designed to enhance distance image quality by reducing chromatic aberration.
Overall Study STARTED	69 138
Overall Study Implanted With CPO Pro IOL Model PAYWT0	69 69
Overall Study Implanted With CPO IOL Model CNWTT0	68 68
Overall Study COMPLETED	69 137
Overall Study NOT COMPLETED	0 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clareon PanOptix Pro vs. Clareon PanOptix - Study B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPO Pro IOL / CPO IOL n=68 Participants CPO Pro IOL Model PAYWT0 implanted in one eye with CPO IOL Model CNWTT0 implanted in the other eye, as randomized. The second eye surgery occurred approximately 7-14 days after the first eye surgery.
Age, Continuous	68.9 years STANDARD_DEVIATION 6.69 • n=4 Participants
Sex: Female, Male Female	44 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants
Race/Ethnicity, Customized White	54 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	3 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=4 Participants
Region of Enrollment United States	68 participants n=4 Participants

PRIMARY outcome

Timeframe: Month 2 postoperative

Population: All Implanted Analysis Set: All subjects with successful contralateral implantation, with at least one postoperative visit (same postoperative visit for both eyes).

Outcome measures

Outcome measures
Measure	CPO Pro IOL n=68 eyes CPO Pro IOL Model PAYWT0 implanted in one eye during cataract surgery	CPO IOL n=68 eyes CPO IOL Model CNWTT0 implanted in one eye during cataract surgery
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)	-0.016 logMAR Standard Deviation 0.1035	0.010 logMAR Standard Deviation 0.0905

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CPO Pro IOL (Ocular Adverse Events)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

CPO IOL (Ocular Adverse Events)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Systemic (Nonocular Adverse Events)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=69 participants at risk Adverse events occurring prior to attempted implantation with the IOL, including ocular adverse events in the second surgical eye that may have occurred prior to second eye attempted implantation.	CPO Pro IOL (Ocular Adverse Events) n=69 participants at risk Ocular adverse events occurring after attempted implantation with CPO Pro IOL	CPO IOL (Ocular Adverse Events) n=68 participants at risk Ocular adverse events occurring after attempted implantation with CPO IOL	Systemic (Nonocular Adverse Events) n=69 participants at risk Nonocular adverse events occurring after attempted implantation with the IOL
Eye disorders Cystoid macular oedema	0.00% 0/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	0.00% 0/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	1.5% 1/68 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
Infections and infestations Pneumonia	0.00% 0/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	1.4% 1/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	1.4% 1/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.

Other adverse events

Other adverse events
Measure	Pretreatment n=69 participants at risk Adverse events occurring prior to attempted implantation with the IOL, including ocular adverse events in the second surgical eye that may have occurred prior to second eye attempted implantation.	CPO Pro IOL (Ocular Adverse Events) n=69 participants at risk Ocular adverse events occurring after attempted implantation with CPO Pro IOL	CPO IOL (Ocular Adverse Events) n=68 participants at risk Ocular adverse events occurring after attempted implantation with CPO IOL	Systemic (Nonocular Adverse Events) n=69 participants at risk Nonocular adverse events occurring after attempted implantation with the IOL
Eye disorders Posterior capsule opacification	0.00% 0/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	8.7% 6/69 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	8.8% 6/68 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.	— 0/0 • 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). All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.

Additional Information

Director Clinical Trial Management, Surgical IOL

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER