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

COMPLETEDNA

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

Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population

NCT04528069•Alcon Research

View on ClinicalTrials.gov

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.

Detailed Description

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye. Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months. This study will be conducted in Australia.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
•Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
•Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;

Exclusion Criteria

•Preoperative irregular astigmatism;
•Clinically significant corneal abnormalities;
•Glaucoma;
•History of or current retinal disease; anterior or posterior segment inflammation;
•Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);

Locations (4)

Alcon Investigator 8117

Campsie, New South Wales, Australia

Alcon Investigator 7678

Sydney, New South Wales, Australia

Alcon Investigator 7813

Footscray, Victoria, Australia

Alcon Investigator 8122

Saint Albans, Victoria, Australia

Key Dates

Start Date

November 16, 2020

Primary Completion Date

December 17, 2021

Completion Date

December 17, 2021

Last Updated

December 30, 2022

Enrollment

ACTUAL participants

Conditions

AphakiaCorneal Astigmatism

Interventions

ACRYSOF® IQ PanOptix® Toric Trifocal IOL

DEVICE

Cataract surgery

PROCEDURE

Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique

NCT06102109

Lens LuxationIOL Subluxation+2 more

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COMPLETEDNA

Evaluation of Clareon Vivity/Vivity Toric

NCT05852470

Aphakia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique

Evaluation of Clareon Vivity/Vivity Toric

Clinical Investigation of Two Tecnis Investigational Lenses

Clareon Toric vs Eyhance Toric

Clareon IOL Retrospective Data Collection

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens