Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Not Applicable

Completed

• Conditions: Aphakia; Corneal Astigmatism
• Interventions: Device: ACRYSOF IQ PanOptix Toric Trifocal IOL; Procedure: Cataract surgery

• Registration Number: NCT04542525
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-09
• Study Start: 2020-12-01
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2022-07
• Results First Submitted: 2022-07-22
• Results First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Results First Posted: 2022-08-17
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PanOptix Toric Trifocal IOL	Cataract surgery	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.
PanOptix Toric Trifocal IOL	ACRYSOF IQ 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.

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	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 Outcome Measures

Name	Time	Method
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)	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.
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇯🇵 Chiyoda-Ku, Tokyo, Japan