Post-Market Clinical Investigation of the Clareon® IOL

Alcon

Status: Completed

Conditions: Cataract; Aphakia

Treatments: Device: Clareon® IOL; Procedure: Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03316885

ILJ466-P003

Details and patient eligibility

About

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Full description

Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).

Enrollment: 245 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed with bilateral cataracts
• Planned small incision cataract removal surgery
• Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits

Key Exclusion Criteria:

• Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
• Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
• Pregnant or lactating, current or planned during the course of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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245 participants in 1 patient group

Clareon IOL

Experimental group

Description:

Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery

Treatment:

Procedure: Cataract Surgery

Device: Clareon® IOL