An interventional study of CPO Pro IOL and CPO IOL in Aphakia and Presbyopia, sponsored by Alcon Research. Completed at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 71 is below the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
Device: CPO Pro IOL · Device: CPO IOL · Procedure: Cataract Surgery
CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
Device: CPO Pro IOL · Device: CPO IOL · Procedure: Cataract Surgery
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.
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 distance visual acuity.
Also known as: Clareon PanOptix, Model CNWTT0
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
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.
Time frame: Month 2 postoperative
| Milestone | CPO Pro IOL / CPO IOL |
|---|---|
| Started | 69 |
| Implanted with cpo pro iol model paywt0 | 69 |
| Implanted with cpo iol model cnwtt0 | 68 |
| Completed | 69 |
| Not completed | 0 |
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.
| logMAR | CPO Pro IOL | CPO IOL |
|---|---|---|
| Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | -0.016 ± 0.1035 | 0.010 ± 0.0905 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/69 (0%) | 0/69 (0%) | 0/69 (0%) |
| CPO Pro IOL (Ocular Adverse Events) | — | 0/69 (0%) | 6/69 (8.7%) |
| CPO IOL (Ocular Adverse Events) | — | 1/68 (1.5%) | 6/68 (8.8%) |
| Systemic (Nonocular Adverse Events) | 0/69 (0%) | 2/69 (2.9%) | 0/69 (0%) |
| Event | Pretreatment | CPO Pro IOL (Ocular Adverse Events) | CPO IOL (Ocular Adverse Events) | Systemic (Nonocular Adverse Events) |
|---|---|---|---|---|
| Cystoid macular oedemaEye disorders | 0/69 | 0/69 | 1/68 | — |
| PneumoniaInfections and infestations | 0/69 | — | — | 1/69 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 0/69 | — | — | 1/69 |
| Event | Pretreatment | CPO Pro IOL (Ocular Adverse Events) | CPO IOL (Ocular Adverse Events) | Systemic (Nonocular Adverse Events) |
|---|---|---|---|---|
| Posterior capsule opacificationEye disorders | 0/69 | 6/69 | 6/68 | — |
All Implanted Analysis Set: All subjects with successful contralateral implantation, with at least one postoperative visit (same postoperative visit for both eyes).
| Age, Continuous(years) | CPO Pro IOL / CPO IOL |
|---|---|
| Mean | 68.9 ± 6.69 |
| Sex: Female, Male(Participants) | CPO Pro IOL / CPO IOL |
|---|---|
| Female | 44 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | CPO Pro IOL / CPO IOL |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 63 |
| Unknown or Not Reported | 2 |
| Race/Ethnicity, Customized(Participants) | CPO Pro IOL / CPO IOL |
|---|---|
| White | 54 |
| Black or African American | 11 |
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Other | 0 |
| Region of Enrollment(participants) | CPO Pro IOL / CPO IOL |
|---|---|
| United States | 68 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2024 to primary completion in Dec 2024, 5 months.
Results were first posted in Jan 2026, 1 year after primary completion.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 5 months is below that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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