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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPO Pro IOL | Experimental | 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. |
|
| CPO IOL | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPO Pro IOL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 2 postoperative |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States | ||
| Grosinger, Spigelman & Grey Eye Surgeons, P.C. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All-Implanted Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All-Implanted Analysis Set | Posted | Mean | Standard Deviation | logMAR | Month 2 postoperative | eyes | eyes |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular oedema | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Trial Management, Surgical IOL | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2025 | Nov 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2024 | Nov 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D011305 | Presbyopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Contralateral (split face) study design
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|
|
| CPO IOL | Device | 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. |
|
| Bloomfield Hills |
| Michigan |
| 48302 |
| United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Vision for Life | Nashville | Tennessee | 37205 | United States |
| Houston Eye Associates | Houston | Texas | 77008 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
CPO IOL Model CNWTT0 implanted in one eye during cataract surgery |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | CPO Pro IOL Model PXYWT0 | Ocular adverse events occurring after attempted implantation with the IOL | 0 | 0 | 1 | 83 | 6 | 83 |
| EG002 | CPO IOL Model CNWTT0 | Ocular adverse events occurring after attempted implantation with the IOL | 0 | 0 | 3 | 83 | 8 | 83 |
| EG003 | Systemic | Nonocular adverse events occurring after attempted implantation with the IOL (CPO PRO IOL or CPO IOL) | 0 | 83 | 2 | 83 | 0 | 83 |
| Dry age-related macular degeneration | Eye disorders | MedDRA (27.0) | Systematic Assessment |
|
| Epiretinal membrane | Eye disorders | MedDRA (27.0) | Systematic Assessment |
|
| Halo vision | Eye disorders | MedDRA (27.0) | Systematic Assessment |
|
| Vitreoretinal traction syndrome | Eye disorders | MedDRA (27.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA (27.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.