AphakiaNCT06400745
Clareon PanOptix Pro vs. Clareon PanOptix - Study A
A study testing CPO Pro IOL, CPO IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Presbyopia
- What is being tested?
- CPO Pro IOL, CPO IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Jun 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, 48302
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Houston Eye Associates
Houston, Texas, 77008
Moyes Eye Center
Kansas City, Missouri, 64154
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Vision for Life
Nashville, Tennessee, 37205
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
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.
Read the detailed description
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.
- Conditions
- Aphakia, Presbyopia
- Being tested
- CPO Pro IOL, CPO IOL, Cataract surgery
- Keywords
- Cataract, IOL
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPO Pro IOLDevice
Also called Clareon PanOptix Pro, Model PXYWT0
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.
CPO IOLDevice
Also called 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 surgeryProcedure or surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CPO Pro IOL; Device: CPO IOL; Procedure: Cataract 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. Receives: Device: CPO Pro IOL; Device: CPO IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start18 Jun 2024
- Primary completion13 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contralateral (split face) study design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400745
- Sponsor's protocol ID
- ILQ137-C002-A
- Status last verified
- Dec 2025
- First submitted
- 2 May 2024
- Last updated
- 12 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
- ClinicalTrials.gov ID
- NCT06400745
- Acronym / sponsor ID
- ILQ137-C002-A
- Conditions
- Aphakia, Presbyopia
- Keywords
- Cataract, IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Posted 12 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Contralateral (split face) study design
| Arm | Type | Receives |
|---|---|---|
| CPO Pro IOL | Experimental | Device: CPO Pro IOL, Device: CPO IOL, Procedure: Cataract surgeryCPO 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 | Device: CPO Pro IOL, Device: CPO IOL, Procedure: Cataract surgeryCPO 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPO Pro IOLAlso: Clareon PanOptix Pro, Model PXYWT0Intraocular 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. | Device | CPO IOL, CPO Pro IOL |
| CPO IOLAlso: Clareon PanOptix, Model CNWTT0Intraocular 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. | Device | CPO IOL, CPO Pro IOL |
| Cataract surgeryExtraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL. | Procedure or surgery | CPO IOL, CPO Pro IOL |
Primary outcome
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Clinical Trial Lead, Surgical study director
Alcon Research, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPO Pro IOL, CPO IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) (time frame: Month 2 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.