RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

RxSight

Status

Enrolling

Conditions

Cataract

Aphakia

Treatments

Device: Control IOL

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Study type

Interventional

Funder types

Industry

Identifiers

CSP-029

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.