N/A
N=500
RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
Aphakia · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT05202808 ↗Enrolled (actual)
500
Serious AEs
1.8%
Results posted
Apr 2025
Primary outcome: Primary: Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control — 0.210; 0.345 Diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Light Adjustable lens (LAL) and Light Delivery Device (LDD) (Device); Control IOL (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- RxSight, Inc.
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control |
0.210; 0.345 | — |
| PRIMARY Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control |
0.262; 0.820 | — |
| SECONDARY Rate of Endothelial Cell Density Loss |
5.1; 4.9 | <0.0001 sig |
| SECONDARY Rate of Retinal Findings |
— | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT05202808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.