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Enrolling by Invitation

NCT Number: NCT07347379

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

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".

Enrolling by Invitation

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Key information

Conditions

Aphakia Cataract

Sex eligibility

All sexes

Study type

Observational

Primary location

Focal Point Vision

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Experimental treatment group received Light adjustable lens with Light delivery Device treatments

Control IOL

Device

Control treatment group received a Control IOL

Primary outcomes

  1. 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

  2. Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group

    Time frame: Up to 55 months

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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