Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: AcrySof® IQ PanOptix™ IOL

Detailed Description

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0011
    • Alcon Investigative Site
  • Tokyo, Japan, 101-0061
    • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to comprehend and sign a statement of informed consent;
• Willing and able to complete all required postoperative visits;
• Cataracts in both eyes with planned cataract removal by phacoemulsification;
• Calculated lens power within the available range;
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
• Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion Criteria:

• Significant irregular corneal aberration as demonstrated by corneal topography;
• Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
• Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
• Previous refractive surgery;
• Diabetic retinopathy
• Other eye conditions as specified in the protocol
• Pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PanOptix IOL; AcrySof® IQ PanOptix™ IOL, bilateral implantation	Device: AcrySof® IQ PanOptix™ IOL; Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient; Other Names: Model TFNT00

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)	Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)	VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.	Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Trifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ILH297-C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes