Actively Recruiting
Clareon TruPlus Single-Arm Study of Monofocal Intraocular Lenses for Cataract Surgery
Led by Alcon Research · Updated on 2026-06-03
122
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study aims to gather safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs), which are devices implanted in the eye during cataract surgery to restore clear vision after removal of the cloudy natural lens. The study focuses on patients diagnosed with bilateral cataracts, including those with astigmatism suitable for correction with toric IOL models. The lenses are intended to remain in the eyes for the patient's lifetime. Participants will be implanted with either the Clareon TruPlus Monofocal Non-Toric or Toric IOL based on recommendations from an IOL calculator. The cataract surgery uses a minimally invasive technique called phacoemulsification to remove the natural lens before implantation. The study includes one preoperative visit, two surgical visits with the second eye surgery occurring 0 to 14 days after the first, and five postoperative visits, spanning approximately 13 months of participation. Throughout the study, participants will undergo assessments of binocular photopic best corrected distance visual acuity (BCDVA) at preoperative day 0 and at 1, 3, and 12 months after surgery. Researchers will monitor vision outcomes and the performance of the implanted lenses. The study involves regular follow-up visits and evaluations to ensure participant safety and to collect detailed data on visual acuity over time.
CONDITIONS
Brief Title
Clareon TruPlus Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.2 logMAR or better in each eye
- Astigmatism suitable for correction with available toric intraocular lens models
- Other protocol-specified inclusion criteria may apply
You will not qualify if you...
- Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other specified eye conditions
- Moderate to severe dry eye that would affect study measurements
- Other protocol-specified exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 0 to 14 days for second eye surgery after first eye surgery
Participants undergo implantation of the Clareon TruPlus Monofocal Intraocular Lens following removal of the clouded natural lens using phacoemulsification surgery.
1 preoperative visit and 2 surgical visits
Duration - Approximately 13 months including follow-up
Participants attend follow-up visits to monitor recovery and assess visual outcomes after surgery.
5 postoperative visits
Trial Site Locations
Total: 5 locations
1
Eye Doctors of Arizona
Phoenix, Arizona, United States, 85028
Actively Recruiting
2
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
Actively Recruiting
3
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
4
Berkeley Eye Center
Sugar Land, Texas, United States, 77478
Actively Recruiting
5
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Actively Recruiting
Research Team
A
Alcon Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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