NCT07502456

Clareon TruPlus Study

Clareon TruPlus Single-Arm Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aphakia
• Astigmatism

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2026-03-31
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study