Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Alcon

Status: Completed

Conditions: Corneal Astigmatism; Aphakia

Treatments: Device: ACRYSOF IQ PanOptix Toric Trifocal IOL; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04542525

ILX140-C001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

PanOptix Toric Trifocal IOL

Experimental group

Description:

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.

Treatment:

Procedure: Cataract surgery

Device: ACRYSOF IQ PanOptix Toric Trifocal IOL