Clareon TruPlus Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alcon Research
Study ID
NCT07502456
Status
Recruiting
Apply to this trial

Conditions

  • Aphakia
  • Astigmatism

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clareon TruPlus Monofocal Non-Toric IOL — DEVICE
    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.
  • Clareon TruPlus Monofocal Toric IOL — DEVICE
    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.
  • Phacoemulsification — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Clareon TruPlus Monofocal IOL
    Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification

Primary Outcome Measure

Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: Day 0 preoperative, Month 1, Month 3, Month 12 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Eye Doctors of ArizonaPhoenixArizona85028-
Cleveland Eye ClinicBrecksvilleOhio44141-
Carolina Eyecare Physicians LLCMt. PleasantSouth Carolina29464-
Berkeley Eye CenterSugar LandTexas77478-
The Eye Institute of UtahSalt Lake CityUtah84107-

Find similar trials in Phoenix, AZ

By research site
Eye Doctors of Arizona· Phoenix, AZCleveland Eye Clinic· Brecksville, OHCarolina Eyecare Physicians LLC· Mt. Pleasant, SCBerkeley Eye Center· Sugar Land, TXThe Eye Institute of Utah· Salt Lake City, UT

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