Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

January 8, 2026 updated by: RxSight, Inc.
This is an observational, follow up study of subjects previously enrolled in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study". The primary objective of this study is to collect long-term safety and effectiveness data on RxSight LAL and Control IOL in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Focal Point Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include up to 500 subjects who previously participated in the CSP-029 study.

Description

Inclusion Criteria:

  • Subject and study eye with prior participation in the CSP-029 study.

Exclusion Criteria:

  • Subjects with serious co-morbid conditions that in the judgment of the investigator makes inclusion in the study not in the best interest of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Experimental treatment group received Light adjustable lens with Light delivery Device treatments
Control IOL
Device: Control IOL
Control treatment group received a Control IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit compared between the RxSight LAL and Control group
Time Frame: Up to 55 months
Up to 55 months
Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group
Time Frame: Up to 55 months
Up to 55 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RxSight, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSP-1003

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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