RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

NCT05202808 | Completed Results FDA Device

• 1 other identifier: CSP-029
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 14

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.

Conditions

Aphakia; Cataract

Keywords

Light Adjustable Lens; LAL; Intraocular lens

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of Endothelial Cell Density Loss

  Postop Month 6

• Rate of Retinal Findings

  Postop Month 6

Study Arms (2)

Light adjustable lens (LAL) and Light Delivery Device (LDD)

EXPERIMENTAL

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Control IOL

ACTIVE COMPARATOR

Device: Control IOL

Interventions

Light Adjustable lens (LAL) and Light Delivery Device (LDD) DEVICE

Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

Light adjustable lens (LAL) and Light Delivery Device (LDD)

Control IOL DEVICE

Control treatment group will receive a Control IOL

Control IOL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RxSight, Inc.: lead

Study Sites (14)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Reeve Woods Eye Center

Chico, California, 95926, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Newsom Eye

Sebring, Florida, 33870, United States

Location

Vance Thompson Vision

Alexandria, Minnesota, 56308, United States

Location

Vance Thompson Vision

Omaha, Nebraska, 68137, United States

Location

Center for Sight

Las Vegas, Nevada, 89145, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75235, United States

Location

Slade & Baker Vision

Houston, Texas, 77027, United States

Location

Texas Eye Research Center

Hurst, Texas, 76054, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Director, Clinical Trials
• Organization: RxSight, Inc.

dgoffredo@rxsight.com

9494215463

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 2:1 to undergo experimental or control treatment.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 24, 2022
• Study Start: December 3, 2021
• Primary Completion: September 11, 2024
• Study Completion: December 16, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)