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Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

NCT04528069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-12-30

Study results available
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Summary

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Conditions

  • Aphakia
  • Corneal Astigmatism

Interventions

DEVICE

ACRYSOF® IQ PanOptix® Toric Trifocal IOL

Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.

PROCEDURE

Cataract surgery

Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Trial Lead, CDMA Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Device
Yes

Countries

  • Australia

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 NCT04528069 on ClinicalTrials.gov