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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Novel Trifocal IOL
- ClinicalTrials.gov ID
- NCT07587138
- Acronym / sponsor ID
- ILW559-C003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
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 understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPYWT0 / PXYWT0 | Other | Device: LPYWT0, Device: PXYWT0, Procedure: Cataract SurgeryInvestigational 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. |
| PXYWT0 / LPYWT0 | Other | Device: LPYWT0, Device: PXYWT0, Procedure: Cataract SurgeryClareon 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| LPYWT0Investigational 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. | Device | LPYWT0 / PXYWT0, PXYWT0 / LPYWT0 |
| PXYWT0Also: Clareon® PanOptix® ProCommercially 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. | Device | LPYWT0 / PXYWT0, PXYWT0 / LPYWT0 |
| Cataract SurgeryRemoval of the cataractous lens by phacoemulsification followed by implantation of the IOL | Procedure or surgery | LPYWT0 / PXYWT0, PXYWT0 / LPYWT0 |
Primary outcome
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Month 6 postoperative
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- EducationalLink provided by the sponsor.
- 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.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPYWT0, PXYWT0 and Cataract Surgery in people with Aphakia and Cataract, run by Alcon Research at 5 sites in 3 countries.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, Philippines, Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinf@alcon.com), or a site near the patient. 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 6 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 21 Oct 2026.