Clareon TruPlus Study

Purpose

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

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • 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.
    Other names:
    • Models REYWT0, REYAT0, RECWT0, RECAT0
  • 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.
    Other names:
    • Models REYWT3, REYWT4, REYWT5, REYAT3, REYAT4, REYAT5, RECWT3, RECWT4, RECWT5, RECAT3, RECAT4, RECAT5.
  • 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

Recruiting Locations

Eye Doctors of Arizona
Phoenix, Arizona 85028

Cleveland Eye Clinic
Brecksville, Ohio 44141

Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina 29464

Berkeley Eye Center
Sugar Land, Texas 77478

The Eye Institute of Utah
Salt Lake City, Utah 84107

More Details

Status
Recruiting
Sponsor
Alcon Research

Study Contact

Alcon Call Center
1-888-451-3937
alcon.medinfo@alcon.com

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.