Clareon TruPlus Single-Arm Study
Alcon Research
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.
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 measureme…
Interventions
- DeviceClareon 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.
- DeviceClareon 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.
- ProcedurePhacoemulsification
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
Locations (2)
- Eye Doctors of ArizonaPhoenix, Arizona
- The Eye Institute of UtahSalt Lake City, Utah