MedTrace Logo

A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

NCT04177771 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-07

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).

Conditions

Interventions

DEVICE

Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population

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

DEVICE

SofPort LI61AO IOL

Control treatment group will receive SofPort LI61AO IOL

DEVICE

Tecnis ZCB00 or ZTC150 IOL

Control treatment group will receive Tecnis ZCB00 or ZTC150 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
2019-11-15
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04177771 on ClinicalTrials.gov