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

Not Applicable

Completed

• Conditions: Aphakia; Astigmatism; Presbyopia
• Interventions: Device: AcrySof IQ PanOptix IOL; Device: AcrySof IQ PanOptix Toric IOL

• Registration Number: NCT06166901
• Lead Sponsor: Alcon Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Study Start: 2024-04-27
• Primary Completion: 2025-02-05
• Study Completion: 2025-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AcrySof IQ PanOptix IOL - Non Toric	AcrySof IQ PanOptix IOL	Implantation with AcrySof IQ PanOptix non toric IOL in both eyes 3-5 years prior to enrollment
AcrySof IQ PanOptix IOL - Toric	AcrySof IQ PanOptix Toric IOL	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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	Preoperative to Visit 1 (Year 3-5 postoperative)	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)
Number of Device Deficiencies	Preoperative to Visit 1 (Year 3-5 postoperative)	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
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)	Visit 1 (Year 3-5 postoperative)	BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).

Trial Locations

Locations (7)

Hospital Universitari General de Catalunya; 🇪🇸 Sabadell, Barcelona, Spain

Oftalvist Jerez - HLA Puerta del Sur; 🇪🇸 Jerez De La Frontera, Cadiz, Spain

Barraquer Ophthalmology Center; 🇪🇸 Barcelona, Spain

Institut Catala de la Retina - Sarria; 🇪🇸 Barcelona, Spain

Hospital Arruzafa; 🇪🇸 Cordoba, Spain

Miranza IOA; 🇪🇸 Madrid, Spain

Clinicas Novovision - Clinica Madrid; 🇪🇸 Madrid, Spain