RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Device: Control IOL

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Chico, California, United States, 95926
      • Reeve Woods Eye Center
  • Florida
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
    • Sebring, Florida, United States, 33870
      • Newsom Eye
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Vance Thompson Vision
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Vance Thompson Vision
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Center for Sight
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Eyecare Physicians, LLC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision Clinic
  • Texas
    • Dallas, Texas, United States, 75235
      • Key-Whitman Eye Center
    • Houston, Texas, United States, 77027
      • Slade & Baker Vision
    • Hurst, Texas, United States, 76054
      • Texas Eye Research Center
    • San Antonio, Texas, United States, 78229
      • Focal Point Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Active Comparator: Control IOL	Device: Control IOL; Control treatment group will receive a Control IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Rate of Endothelial Cell Density Loss	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.	Postop Month 6
Rate of Retinal Findings	Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.	Postop Month 6

Collaborators and Investigators

• Sponsor: RxSight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): September 11, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Intraocular lens; Light Adjustable Lens; LAL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: CSP-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No