Clareon TruPlus Study
Clareon TruPlus Single-Arm Study
1 other identifier
interventional
122
1 country
5
Brief Summary
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Typical duration for not_applicable
5 active sites
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
March 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
May 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 3, 2026
June 1, 2026
2 years
March 26, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
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
Day 0 preoperative, Month 1, Month 3, Month 12
Study Arms (1)
Clareon TruPlus Monofocal IOL
EXPERIMENTALImplantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification
Interventions
Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
Minimally invasive surgery technique that utilizes ultrasonic vibrations to break up (emulsify) and remove a cloudy lens through a small, self-sealing, 2-3mm incision
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (5)
Eye Doctors of Arizona
Phoenix, Arizona, 85028, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, 29464, United States
Berkeley Eye Center
Sugar Land, Texas, 77478, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Surgical
Alcon Research, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2026
First Posted
March 31, 2026
Study Start
May 26, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share