Clinical trial Recruiting at 5 sites Interventional Ages 22 and up

Clareon TruPlus IOLs in Bilateral Cataract Surgery

Official title: Clareon TruPlus Single-Arm Study

Run by Alcon Research · NCT07502456 · Data updated 2026-11-12

This study tests Clareon TruPlus Monofocal IOLs to see how safe they are and how well they perform for people with both eyes affected by cataracts.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment185 (estimated)
SponsorAlcon Research
Industry-sponsored
Locations5 sites (Phoenix, Arizona and 4 other locations)
StatusRecruiting
StartedMay 26, 2026
Main results expectedJune 2028
Study endsJune 2028
Registry record updatedOctober 30, 2026
Trial IDNCT07502456 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with bilateral cataracts planning bilateral cataract extraction and toric or non-toric IOL needs, as judged suitable by an investigator.

Probably not a fit

Patients with exclusion criteria such as AMD, glaucoma, or significant dry eye that could affect measurements may not benefit from the device or study outcomes.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study implants Clareon TruPlus Monofocal intraocular lenses (IOLs) during cataract surgery to gather safety and performance data. Participants may receive either non-toric or toric IOLs based on an IOL calculator recommendation. The study involves eight visits over about 13 months, including preoperative, two surgical, and five postoperative visits, with the second-eye surgery typically 0–14 days after the first. Key eligibility targets adults with bilateral cataracts and acceptable best-corrected vision, while excluding eyes with certain retinal or ocular conditions that could affect measurements. Phacoemulsification is the surgical method used, and all procedures are conducted at multiple clinical sites under the lead sponsor Alcon Research.

Why it matters

Potential benefit: If successful, participants may experience safe implantation of Clareon TruPlus IOLs with potential for improved or stable vision after cataract surgery.

How similar studies have gone: Prior studies of Clareon TruPlus or similar IOLs have shown favorable safety and performance in cataract patients, supporting this type of evaluation, though specifics depend on device and population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

* Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.
* Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
* Astigmatism suitable for correction with available toric IOL models.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.
* Moderate to severe dry eye that would affect study measurements.
* Other protocol-specified exclusion criteria may apply.

Where it's running

  • Eye Doctors of Arizona
    Phoenix, Arizona, United States
    Recruiting
  • Cleveland Eye Clinic
    Brecksville, Ohio, United States
    Recruiting
  • Carolina Eyecare Physicians LLC
    Mt. Pleasant, South Carolina, United States
    Recruiting
  • Berkeley Eye Center
    Sugar Land, Texas, United States
    Recruiting
  • The Eye Institute of Utah
    Salt Lake City, Utah, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.