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RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

NCT05202808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-04-20

Study results available
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Summary

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Conditions

  • Aphakia
  • Cataract

Interventions

DEVICE

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

Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

DEVICE

Control IOL

Control treatment group will receive a Control IOL

Sponsors & Collaborators

  • RxSight, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2024-09-11
Completion
2024-12-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202808 on ClinicalTrials.gov