Recruiting

Clareon TruPlus IOLs

Sponsor:

Alcon Research

Code:

NCT07502456

Conditions

Aphakia

Astigmatism

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Clareon TruPlus Monofocal Non-Toric IOL

Clareon TruPlus Monofocal Toric IOL

Phacoemulsification

Study Details

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.

Conditions

Aphakia

Astigmatism

Study ID

NCT07502456

Start date

May 26, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Key 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.

Key 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.

Study Design

Enrollment

122 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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.

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 measure

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

Central Contacts and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

Eye Doctors of Arizona

Recruiting

Phoenix, Arizona, United States, 85028

Cleveland Eye Clinic

Recruiting

Brecksville, Ohio, United States, 44141

Carolina Eyecare Physicians LLC

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Berkeley Eye Center

Recruiting

Sugar Land, Texas, United States, 77478

The Eye Institute of Utah

Recruiting

Salt Lake City, Utah, United States, 84107

More Information

Sponsor

Alcon Research

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Cataract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alcon Research on 2026-06-03.