RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Completed · Not applicable

Conditions studied: Aphakia, Cataract

In brief

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Key facts

Study ID

NCT05202808

Run by

RxSight, Inc.

People needed

500

Starts

2021-12-03

Expected to finish

2024-12-16

Last updated by the study team

2025-04-20

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
• Willing and able to comply with the requirements for study specific procedures and visits.
• Able to complete a written questionnaire in English.

You may not qualify if…

• Pre-existing macular disease in either eye.
• Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
• History of uveitis in either eye.
• Evidence of ectasia in either eye.
• Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
• Subjects taking systemic medication that may increase sensitivity to UV light.
• Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
• History of ocular herpes simplex virus in either eye.

Where it is running

• Vold Vision — Fayetteville, Arkansas, United States
• Reeve Woods Eye Center — Chico, California, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• Newsom Eye — Sebring, Florida, United States
• Vance Thompson Vision — Alexandria, Minnesota, United States
• Vance Thompson Vision — Omaha, Nebraska, United States
• Center for Sight — Las Vegas, Nevada, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Carolina Eyecare Physicians, LLC — Mt. Pleasant, South Carolina, United States
• Vance Thompson Vision Clinic — Sioux Falls, South Dakota, United States
• Key-Whitman Eye Center — Dallas, Texas, United States
• Slade & Baker Vision — Houston, Texas, United States
• Texas Eye Research Center — Hurst, Texas, United States
• Focal Point Vision — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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