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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-13

Study Completion Date

2026-09-30

Brief Summary

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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".

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Detailed Description

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Conditions

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Aphakia Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Intervention Type DEVICE

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

Control IOL

Intervention Type DEVICE

Control treatment group received a Control IOL

Interventions

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

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

Intervention Type DEVICE

Control IOL

Control treatment group received a Control IOL

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No