Status:
COMPLETED
RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
Lead Sponsor:
RxSight, Inc.
Conditions:
Aphakia
Cataract
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05202808
Start Date
December 3 2021
End Date
December 16 2024
Last Update
April 20 2025
Active Locations (14)
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1
Vold Vision
Fayetteville, Arkansas, United States, 72704
2
Reeve Woods Eye Center
Chico, California, United States, 95926
3
The Eye Institute of West Florida
Largo, Florida, United States, 33770
4
Newsom Eye
Sebring, Florida, United States, 33870