Clareon TruPlus Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clareon TruPlus Monofocal Non-Toric IOL, Clareon TruPlus Monofocal Toric IOL, Phacoemulsification.
- Who it may be relevant to
- Registry conditions: Aphakia, Astigmatism. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clareon TruPlus Single-Arm Study
Overview
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.
Detailed description
In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator.
Subjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.
Interventions
- Device Clareon TruPlus Monofocal Non-Toric IOL
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. - Device Clareon TruPlus Monofocal Toric IOL
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. - Procedure Phacoemulsification
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
Primary outcome measures
- Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [Time frame: Day 0 preoperative, Month 1, Month 3, Month 12]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Eye Doctors of Arizona — Phoenix
- Cleveland Eye Clinic — Brecksville
- Carolina Eyecare Physicians LLC — Mt. Pleasant
- Berkeley Eye Center — Sugar Land
- The Eye Institute of Utah — Salt Lake City
Identifiers
NCT: NCT07502456 · ILM335-P001