Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

July 22, 2022 updated by: Alcon Research

Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.

This study will be conducted in Japan.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Chiyoda-Ku, Tokyo, Japan, 101-0061
        • Alcon Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
  • Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Irregular corneal astigmatism.
  • History of anterior segment, posterior segment, or optic nerve pathology.
  • History of previous intraocular or corneal (refractive or trauma related) surgery.
  • Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PanOptix Toric Trifocal IOL
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted.
Procedure: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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
Other Names:
  • PanOptix Toric Trifocal IOL
  • Model TFNT20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Time Frame: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Day 30-60 postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Time Frame: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Day 30-60 postoperative
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
Time Frame: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Day 30-60 postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Japan Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILX140-C001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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