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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia; Astigmatism; Aphakia
• Intervention / Treatment: Device: AcrySof IQ PanOptix IOL; Device: AcrySof IQ PanOptix Toric IOL

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 (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Study Locations

• Spain
  • Barcelona, Spain, 08021
    • Barraquer Ophthalmology Center
  • Barcelona, Spain, 8022
    • Institut Catala de la Retina - Sarria
  • Cordoba, 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 - Non Toric; Implantation with AcrySof IQ PanOptix non toric IOL in both eyes 3-5 years prior to enrollment	Device: AcrySof IQ PanOptix IOL; 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 - Toric; Implantation with AcrySof IQ PanOptix IOL in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with a toric AcrySof IQ PanOptix IOL	Device: AcrySof IQ PanOptix Toric IOL; Toric trifocal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)	BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).	Visit 1 (Year 3-5 postoperative)
Number of Adverse Events (AEs)	Ocular adverse events will be identified from chart review and prospectively at Visit 1. 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)	Preoperative to Visit 1 (Year 3-5 postoperative)
Number of Device Deficiencies	Device deficiencies will be identified from chart review and prospectively at Visit 1. 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	Preoperative to Visit 1 (Year 3-5 postoperative)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

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): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Presbyopia; Astigmatism; 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