RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

NCT ID: NCT05202808

Last Updated: 2025-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2024-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphakia Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized 2:1 to undergo experimental or control treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Control IOL

Group Type ACTIVE_COMPARATOR

Control IOL

Intervention Type DEVICE

Control treatment group will receive a Control IOL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DEVICE

Control IOL

Control treatment group will receive a Control IOL

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RxSight, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vold Vision

Fayetteville, Arkansas, United States

Site Status

Reeve Woods Eye Center

Chico, California, United States

Site Status

The Eye Institute of West Florida

Largo, Florida, United States

Site Status

Newsom Eye

Sebring, Florida, United States

Site Status

Vance Thompson Vision

Alexandria, Minnesota, United States

Site Status

Vance Thompson Vision

Omaha, Nebraska, United States

Site Status

Center for Sight

Las Vegas, Nevada, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Site Status

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, United States

Site Status

Key-Whitman Eye Center

Dallas, Texas, United States

Site Status

Slade & Baker Vision

Houston, Texas, United States

Site Status

Texas Eye Research Center

Hurst, Texas, United States

Site Status

Focal Point Vision

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSP-029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.