Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)

Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Trifocal Toric Intraocular Lens (IOL)

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Aphakia
• Intervention / Treatment: Device: AcrySof IQ PanOptix IOL Toric; Device: AcrySof IQ PanOptix IOL Non-Toric

Detailed Description

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected at Visit 1, which will occur Year 3-5 postoperative.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08021
    • Barraquer Ophthalmology Center
  • Barcelona, Spain, 8022
    • Institut Catala de la Retina - Sarria
  • Córdoba, Spain, 14012
    • Hospital Arruzafa
  • Madrid, Spain, 28033
    • Miranza IOA
  • Madrid, Spain, 28046
    • Clinicas Novovision - Clinica Madrid
  • Barcelona
    • Sabadell, Barcelona, Spain, 8205
      • Hospital Universitari General de Catalunya
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11408
      • Oftalvist Jerez - HLA Puerta del Sur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
• Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a toric lens in one eye and a non-toric in the fellow eye.
• Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.

Exclusion Criteria:

• Subject currently participating in another investigational drug or device study.
• Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation.
• Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment.
• Subject is pregnant or nursing at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AcrySof IQ PanOptix IOL Toric; Subjects categorized to this group were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix IOL Toric	Device: AcrySof IQ PanOptix IOL Toric; Trifocal toric IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.; Other Names: Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60; Device: AcrySof IQ PanOptix IOL Non-Toric; Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.; Other Names: Model TFNT00
Experimental: AcrySof IQ PanOptix IOL Non-Toric; Subjects categorized to this group were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment	Device: AcrySof IQ PanOptix IOL Non-Toric; Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.; Other Names: Model TFNT00

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)	BCDVA was assessed for both eyes together at a distance of 4 meters using letter charts and recorded in logarithm of the minimum angle of resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan. No hypothesis testing was pre-specified for this endpoint.	Year 3-5 postoperative (Visit 1, Day 1)
Number of Eyes Experiencing an Ocular Adverse Event by Toricity	Ocular adverse events were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of ocular adverse events include the following: Cystoid Macular Edema (CME); Hypopyon; Endophthalmitis; Lens dislocation; Pupillary block; Retinal detachment; Secondary Surgical Interventions (explantation/exchange/repositioning) This outcome measure was pre-specified for eye-based reporting.	Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
Number of Subjects Experiencing a Non-Ocular Adverse Event	AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).	Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
Number of Device Deficiencies by Toricity	Device deficiencies were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of device deficiencies include the following: Failure to meet product specifications (e.g., incorrect IOL power); IOL defect; Broken IOL optic; Broken IOL haptic; Scratched IOL optic; Unsealed device packaging; Suspected product contamination; Lack of performance This outcome measure was pre-specified for eye-based reporting.	Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Astigmatism; Presbyopia; Aphakia
• Other Study ID Numbers: ILH297-I001

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