Long-Term Safety and Effectiveness of RxSight Light Adjustable Lens and Control IOL in Previously Implanted Subjects
This study aims to observe the long-term safety and effectiveness of the RxSight Light Adjustable Lens and Control IOL in individuals who have previously undergone implantation.
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: November 13, 2025
Actual date on which the first participant was enrolled.This study focuses on individuals who previously participated in the 'RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study'. The main goal is to gather long-term data on the safety and effectiveness of the RxSight LAL and a control intraocular lens (IOL). These lenses were implanted in the participants during their initial study. The importance of this research lies in understanding the long-term impacts of these lenses, which could potentially improve care and address challenges in the field of eye health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location