ClinicalTrials.gg
RecruitingNCT07587138Updated Oct 21, 2026

Clinical Evaluation of a Novel Trifocal IOL

An interventional study of LPYWT0 and PXYWT0 in Aphakia and Cataract, sponsored by Alcon Research. Recruiting at 5 sites in 3 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 21, 2026Now RecruitingFirst site in Australia+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aphakia
  • Cataract

Browse trials for

03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's planned enrollment of 66 is below the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Other
    LPYWT0 / PXYWT0

    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.

    Device: LPYWT0 · Device: PXYWT0 · Procedure: Cataract Surgery

  • Other
    PXYWT0 / LPYWT0

    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.

    Device: LPYWT0 · Device: PXYWT0 · Procedure: Cataract Surgery

Interventions

  • DeviceLPYWT0

    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.

  • DevicePXYWT0

    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.

    Also known as: Clareon® PanOptix® Pro

  • ProcedureCataract Surgery

    Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Month 6 postoperative

07

Study locations

1 of 5 sites recruiting
  • Personaleyes
    Sydney, New South Wales 2000, Australia
    Not yet recruiting
  • Dr. Agarwal's Eye Hospital Limited
    Chennai, Tamil Nadu 600018, India
    Not yet recruiting
  • Narayana Nethralaya
    Bangalore, 560010, India
    Not yet recruiting
  • Peregrine Eye Laser and Institute
    Makati City, Manila 1209, Philippines
    Not yet recruiting
  • Asian Eye Institute
    Makati City, 1200, Philippines
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 21, 2026
Sites
1 site added — first site in Australia. 4 sites changed recruiting status (3 now not yet recruiting, 1 now recruiting)
Show 4 sites
  • Dr. Agarwal's Eye Hospital Limited · Chennai, Indiano status→Not yet recruiting
  • Narayana Nethralaya · Bangalore, Indiano status→Not yet recruiting
  • Peregrine Eye Laser and Institute · Makati City, Philippinesno status→Not yet recruiting
  • Asian Eye Institute · Makati City, Philippinesno status→Recruiting
Show site
  • Personaleyes · Sydney, Australia
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Australia. 4 sites changed recruiting status (3 now not yet recruiting, 1 now recruiting)
    Show 4 sites
    • Dr. Agarwal's Eye Hospital Limited · Chennai, Indiano status→Not yet recruiting
    • Narayana Nethralaya · Bangalore, Indiano status→Not yet recruiting
    • Peregrine Eye Laser and Institute · Makati City, Philippinesno status→Not yet recruiting
    • Asian Eye Institute · Makati City, Philippinesno status→Recruiting
    Show site
    • Personaleyes · Sydney, Australia
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07587138
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Oct 9, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Alcon Call Center
Contact
alcon.medinf@alcon.com
1-888-451-3937
Clinical Trial Lead, Surgical
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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