NCT07587138

Brief 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 8, 2026

Last Update Submit

May 14, 2026

Conditions

AphakiaCataract

Outcome Measures

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.

    Month 6 postoperative

Study Arms (2)

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.

Device: LPYWT0Device: PXYWT0Procedure: 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.

Device: LPYWT0Device: PXYWT0Procedure: Cataract Surgery

Interventions

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.

LPYWT0 / PXYWT0PXYWT0 / LPYWT0
PXYWT0DEVICE

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
LPYWT0 / PXYWT0PXYWT0 / LPYWT0
Cataract SurgeryPROCEDURE

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

LPYWT0 / PXYWT0PXYWT0 / LPYWT0

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr. Agarwal's Eye Hospital Limited

Chennai, Tamil Nadu, 600018, India

Location

Narayana Nethralaya

Bangalore, 560010, India

Location

Peregrine Eye Laser and Institute

Makati City, Manila, 1209, Philippines

Location

Asian Eye Institute

Makati City, 1200, Philippines

Location

Related Links

MeSH Terms

Conditions

AphakiaCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Clinical Trial Lead, Surgical

    Alcon Research, LLC

    STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937alcon.medinf@alcon.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)PH(2)