Trial Outcomes & Findings for Clareon PanOptix Pro vs. Clareon PanOptix - Study A (NCT NCT06400745)

Last Updated: 2025-12-12

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

87 participants

Primary outcome timeframe

Month 2 postoperative

Results posted on

2025-12-12

Participant Flow

Of the 87 randomized participants, 4 were discontinued after randomization and prior to attempted implantation. This reporting group includes all participants with attempted implantation (83).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	CPO Pro IOL / CPO IOL CPO Pro IOL Model PXYWT0 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.
Overall Study STARTED	83 166
Overall Study Implanted With CPO Pro IOL Model PXYWT0	83 166
Overall Study Implanted With CPO IOL Model CNWTT0	83 166
Overall Study COMPLETED	83 166
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clareon PanOptix Pro vs. Clareon PanOptix - Study A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPO Pro IOL / CPO IOL n=83 Participants CPO Pro IOL Model PXYWT0 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	68.4 years STANDARD_DEVIATION 7.15 • n=26 Participants
Sex: Female, Male Female	56 Participants n=26 Participants
Sex: Female, Male Male	27 Participants n=26 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=26 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants
Race/Ethnicity, Customized White	64 Participants n=26 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=26 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=26 Participants
Race/Ethnicity, Customized Asian	5 Participants n=26 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=26 Participants
Race/Ethnicity, Customized Other	1 Participants n=26 Participants
Region of Enrollment United States	83 participants n=26 Participants

PRIMARY outcome

Timeframe: Month 2 postoperative

Population: All-Implanted Analysis Set

Outcome measures

Outcome measures
Measure	CPO Pro IOL n=83 eyes CPO Pro IOL Model PXYWT0 implanted in one eye during cataract surgery	CPO IOL n=83 eyes CPO IOL Model CNWTT0 implanted in one eye during cataract surgery
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)	0.032 logMAR Standard Deviation 0.0919	0.023 logMAR Standard Deviation 0.0813

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CPO Pro IOL Model PXYWT0

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

CPO IOL Model CNWTT0

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Systemic

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=83 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 Model PXYWT0 n=83 participants at risk Ocular adverse events occurring after attempted implantation with the IOL	CPO IOL Model CNWTT0 n=83 participants at risk Ocular adverse events occurring after attempted implantation with the IOL	Systemic n=83 participants at risk Nonocular adverse events occurring after attempted implantation with the IOL (CPO PRO IOL or CPO IOL)
Eye disorders Cystoid macular oedema	0.00% 0/83 • 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 test or comparator article 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% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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.
Eye disorders Dry age-related macular degeneration	0.00% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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.
Eye disorders Epiretinal membrane	0.00% 0/83 • 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 test or comparator article 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% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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.
Eye disorders Halo vision	0.00% 0/83 • 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 test or comparator article 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% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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.
Eye disorders Vitreoretinal traction syndrome	0.00% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/83 • 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 test or comparator article 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 test or comparator article 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/83 • 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 test or comparator article 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 test or comparator article 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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.
Surgical and medical procedures Intraocular lens implant	0.00% 0/83 • 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 test or comparator article 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% 0/83 • 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 test or comparator article 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.	1.2% 1/83 • Number of events 1 • 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 test or comparator article 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 test or comparator article 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=83 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 Model PXYWT0 n=83 participants at risk Ocular adverse events occurring after attempted implantation with the IOL	CPO IOL Model CNWTT0 n=83 participants at risk Ocular adverse events occurring after attempted implantation with the IOL	Systemic n=83 participants at risk Nonocular adverse events occurring after attempted implantation with the IOL (CPO PRO IOL or CPO IOL)
Eye disorders Posterior capsule opacification	0.00% 0/83 • 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 test or comparator article 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.	7.2% 6/83 • Number of events 6 • 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 test or comparator article 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.	9.6% 8/83 • Number of events 8 • 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 test or comparator article 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 test or comparator article 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