CompletedNot Applicable

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

United States500 participantsStarted 2021-12-03

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control

Timeframe: Postop Month 6

Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

Timeframe: Postop Month 6

Trial details

NCT IDNCT05202808

SponsorRxSight, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-11

Results submitted2025-02-25

View on ClinicalTrials.gov More Aphakia trials

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.