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

N/AEnrolling By InvitationNCT07347379

RxSight, Inc.500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Aphakia Cataract

Interventions

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

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

Control IOLDEVICE

Control treatment group received a Control IOL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Focal Point Vision

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

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

Time frame: Up to 55 months

Data from ClinicalTrials.gov

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