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.
Clareon TruPlus Study
At a glance
Conditions
Where it's being run
5 sites across 5 statesStudy leadership
- Clinical Trial Lead, Surgical · STUDY_DIRECTOR · Alcon Research, LLC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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