RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Not Applicable

Completed

• Conditions: Cataract; Aphakia
• Interventions: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Device: Control IOL

• Registration Number: NCT05202808
• Lead Sponsor: RxSight, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-24
• Primary Completion: 2024-09-11
• Study Completion: 2024-12-16
• Results First Submitted: 2025-02-25
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Results First Posted: 2025-04-20
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Light Adjustable lens (LAL) and Light Delivery Device (LDD)	-
Control IOL	Control IOL	-

Primary Outcome Measures

Name	Time	Method
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control	Postop Month 6
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control	Postop Month 6

Secondary Outcome Measures

Name	Time	Method
Rate of Endothelial Cell Density Loss	Postop Month 6	The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
Rate of Retinal Findings	Postop Month 6	Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

Trial Locations

Locations (13)

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States

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; 🇺🇸 Omaha, Nebraska, United States

Center for Sight; 🇺🇸 Las Vegas, Nevada, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Carolina Eyecare Physicians, LLC; 🇺🇸 Mount Pleasant, South Carolina, United States

Vance Thompson Vision Clinic; 🇺🇸 Sioux Falls, South Dakota, United States

Key-Whitman Eye Center; 🇺🇸 Dallas, Texas, United States

Texas Eye Research Center; 🇺🇸 Hurst, Texas, United States

Focal Point Vision; 🇺🇸 San Antonio, Texas, United States