AphakiaNCT07161635
Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs
A study testing Clareon PanOptix Pro/Pro Toric Trifocal IOL and Phacoemulsification in people with Aphakia and Presbyopia, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near. 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?
- Clareon PanOptix Pro/Pro Toric Trifocal IOL and Phacoemulsification
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Oct 2025to 7 Oct 2026
- Phase
- Interventional
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
- Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);
- Subject must be able to understand and sign an approved informed consent form;
- Subject is willing to complete all the required study visits for the duration of the study;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Ocular conditions as specified in the protocol;
- Subjects who desire monovision correction;
- Previous intraocular or corneal surgery;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Houston Eye Associates
Houston, Texas, 77008
Moyes Eye Center
Kansas City, Missouri, 64154
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, 29464
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.
Read the detailed description
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.
- Conditions
- Aphakia, Presbyopia
- Being tested
- Clareon PanOptix Pro/Pro Toric Trifocal IOL, Phacoemulsification
- Keywords
- Cataract, Eye Surgery
- 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.
Clareon PanOptix Pro/Pro Toric Trifocal IOLDevice
Also called Clareon PanOptix Pro Trifocal IOL Models PXYWT0, PXCWT0, PXYAT0, PXCAT0, Clareon PanOptix Pro Trifocal Toric IOL Models PXYWT3- PXYWT6, PXCWT3-T6, PXYAT3-PXYAT6, PXCAT3-PXCAT6
Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.
PhacoemulsificationProcedure or surgery
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.
| Study group | Role | What they receive |
|---|---|---|
| Clareon PanOptix Pro/Pro Toric Trifocal IOL | Experimental | The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted. Receives: Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL; Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual Acuity (VA) will be assessed for both eyes together (binocular) 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 will be 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 1 and Month 6 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start14 Oct 2025
- Primary completion7 Oct 2026
- Study completion7 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Principal Clinical Trial Operations, Surgical, Study director, Alcon Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161635
- Sponsor's protocol ID
- ILQ137-P001
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No