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

Conditions

• Aphakia Cataract

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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".

Key Dates

Start date

Nov 13, 2025

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Light adjustable lens (LAL) and Light Delivery Device (LDD)
  Light adjustable lens (LAL) and Light Delivery Device (LDD)
• Arm: Control IOL
  Control IOL

Primary Outcome Measure

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 ]

Locations (1)

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