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Completed

NCT Number: NCT04542525

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

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.

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Key information

Conditions

Aphakia Astigmatism Cataract Corneal Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Chiyoda-Ku, Tokyo, 101-0061, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACRYSOF IQ PanOptix Toric Trifocal IOL

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

Other names: PanOptix Toric Trifocal IOL, Model TFNT20

cataract surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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