Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Aphakia Clinical Trial

Official title:

Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542525
• Other study ID #: ILX140-C001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: July 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Corneal Astigmatism

Intervention

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

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

Locations

Country	Name	City	State
Japan	Alcon Investigative Site	Chiyoda-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With = 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	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	Percentage of Eyes With = 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	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
Secondary	Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)	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