Clareon TruPlus Study

Alcon

Status

Not yet enrolling

Conditions

Astigmatism

Aphakia

Treatments

Procedure: Phacoemulsification

Device: Clareon TruPlus Monofocal Toric IOL

Device: Clareon TruPlus Monofocal Non-Toric IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT07502456

ILM335-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.