Clareon TruPlus Study for Aphakia and Astigmatism

This study is testing the safety and performance of new lenses called Clareon TruPlus Monofocal Intraocular Lenses (IOLs). These IOLs are implanted in your eye during cataract surgery to help you see clearly after a cloudy natural lens is removed. Some lenses are designed for people with astigmatism (a common vision problem caused by an imperfectly curved eye surface). The study aims to see how well these lenses help improve your distance vision. You might be able to join if you have cataracts in both eyes and are planning to have cataract surgery. The study is looking for 122 participants.

Study design
This study is testing two types of Clareon TruPlus Monofocal IOLs in about 122 adult participants. The type of IOL you receive will be based on your doctor's recommendation.
What's involved
You will have 8 study visits over approximately 13 months, including one visit before surgery, two surgery visits, and five visits after surgery. Your second eye surgery will happen 0-14 days after the first.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be checked at 1 month, 3 months, and 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07502456

Clareon TruPlus Study

Recruiting
NAAges 22+InterventionalTreatment
Alcon Research
~122 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Clareon TruPlus Monofocal Non-Toric IOLClareon TruPlus Monofocal Toric IOLPhacoemulsification

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Measured over Day 0 preoperative, Month 1, Month 3, Month 12
Aphakia
Astigmatism
5 sites across 5 states
Arizona1
Ohio1
South Carolina1
Texas1
Utah1
  • Clinical Trial Lead, Surgical · STUDY_DIRECTOR · Alcon Research, LLC

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)Day 0 preoperative, Month 1, Month 3, Month 12

    Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint