Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Alcon Research32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aphakia Corneal Astigmatism

Interventions

ACRYSOF IQ PanOptix Toric Trifocal IOLDEVICE

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 surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alcon Investigative Site

Chiyoda-Ku, Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Day 30-60 postoperative

Secondary Outcomes

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.

Time frame: Day 30-60 postoperative

Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)

Time frame: Day 30-60 postoperative

Data from ClinicalTrials.gov

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