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Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

NCT03660865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-12-23

Study results available
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Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

Conditions

  • Aphakia
  • Cataract

Interventions

DEVICE

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

Primary eye will receive Light adjustable lens with Light delivery Device treatments

DEVICE

Control IOL

Fellow eye will receive control IOL

Sponsors & Collaborators

  • RxSight, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2020-04-01
Completion
2020-04-01
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 NCT03660865 on ClinicalTrials.gov