Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

NCT ID: NCT04542525

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-08-10

Brief Summary

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.

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.

Conditions

Aphakia; Corneal Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ACRYSOF IQ PanOptix Toric Trifocal IOL

Intervention Type: DEVICE

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

Cataract surgery

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: DEVICE

Cataract surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

PanOptix Toric Trifocal IOL; Model TFNT20

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Trial Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Japan Limited

Locations

Alcon Investigative Site

Chiyoda-Ku, Tokyo, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ILX140-C001

Identifier Type: -

Identifier Source: org_study_id