AphakiaNCT07587138
Clinical Evaluation of a Novel Trifocal IOL
A study testing LPYWT0, PXYWT0 and Cataract Surgery in people with Aphakia and Cataract, run by Alcon Research at 5 sites in 3 countries.
Trial summary
The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. Read more about this study
- Who is it for?
- Ages 22 years and older
- What is being tested?
- LPYWT0, PXYWT0 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
- 66 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 Oct 2026to Jul 2027
- 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
- The calculated power needed for the artificial lens (IOL) must be between +15.0 and +25.0 D in each eye, designed to bring subject vision as close to "0.0" (neutral) as possible, meaning they will not be strongly nearsighted or farsighted after surgery.
- Subjects must have low levels of astigmatism (misshapen cornea) in the eyes (less than 1.00 D).
- In the doctor's opinion, the subjects have the potential to achieve good vision (0.2 logMAR, which is roughly 20/32 Snellen or better) in each eye after the surgery, when wearing the best possible spectacles or contact lenses.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Clinically significant corneal diseases which may, according to the investigator's medical opinion, adversely affect visual outcomes.
- Any ocular or systemic health condition or medical issue that, in the investigator's medical opinion, could make the study results unreliable, prevent the person from finishing the study, or increase their safety risk.
- People who want to have one eye set for distance vision and the other for near vision.
- The doctor expects significant blurry vision (astigmatism) after the procedure.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
India2 sites, 2 recruiting
- Not yet recruiting
Narayana Nethralaya
Bangalore, 560010
- Not yet recruiting
Dr. Agarwal's Eye Hospital Limited
Chennai, Tamil Nadu, 600018
Philippines2 sites, 2 recruiting
- Not yet recruiting
Peregrine Eye Laser and Institute
Makati City, Manila, 1209
- Recruiting
Asian Eye Institute
Makati City, 1200
Australia1 site, 1 recruiting
- Not yet recruiting
Personaleyes
Sydney, New South Wales, 2000
About this study
The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.
Read the detailed description
In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months.
This study is planned to be conducted in India and the Philippines.
- Being tested
- LPYWT0, PXYWT0, Cataract Surgery
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPYWT0Device
Investigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
PXYWT0Device
Also called Clareon® PanOptix® Pro
Commercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
Cataract SurgeryProcedure or surgery
Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL
| Study group | Role | What they receive |
|---|---|---|
| LPYWT0 / PXYWT0 | Other | Investigational IOL Model LPYWT0 implanted in the first operative eye during cataract surgery with Clareon PanOptix Pro IOL Model PXYWT0 in the second eye, as randomized. The second eye will be implanted 7-14 days after the first. Receives: Device: LPYWT0; Device: PXYWT0; Procedure: Cataract Surgery |
| PXYWT0 / LPYWT0 | Other | Clareon PanOptix Pro IOL Model PXYWT0 implanted in the first operative eye during cataract surgery with investigational IOL Model LPYWT0 implanted in the second eye, as randomized. The second eye will be implanted 7-14 days after the first. Receives: Device: LPYWT0; Device: PXYWT0; 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 will be assessed using letter charts under well-lit (photopic) conditions with correction in place at a distance of 4 meters from the subject. BCDVA will be recorded in logarithm minimum angle of resolution (logMAR) where 0.0 logMAR is equivalent to 20/20 Snellen, or normal distance eyesight, and negative logMAR values represent better-than-normal distance eyesight.
Measured: 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 posted14 May 2026
- Study start9 Oct 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587138
- Sponsor's protocol ID
- ILW559-C003
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No