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

NCT06166901 | Completed Results FDA Device

• 1 other identifier: ILH297-I001
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Aphakia; Astigmatism; Presbyopia

Keywords

Cataract surgery

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

AcrySof IQ PanOptix IOL Toric

EXPERIMENTAL

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; Device: AcrySof IQ PanOptix IOL Non-Toric

AcrySof IQ PanOptix IOL Non-Toric

EXPERIMENTAL

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

Interventions

AcrySof IQ PanOptix IOL Toric DEVICE

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.

Also known as: Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60

AcrySof IQ PanOptix IOL Toric

AcrySof IQ PanOptix IOL Non-Toric DEVICE

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.

Also known as: Model TFNT00

AcrySof IQ PanOptix IOL Non-Toric; AcrySof IQ PanOptix IOL Toric

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (7)

Hospital Universitari General de Catalunya

Sabadell, Barcelona, 8205, Spain

Location

Oftalvist Jerez - HLA Puerta del Sur

Jerez de la Frontera, Cadiz, 11408, Spain

Location

Barraquer Ophthalmology Center

Barcelona, 08021, Spain

Location

Institut Catala de la Retina - Sarria

Barcelona, 8022, Spain

Location

Hospital Arruzafa

Córdoba, 14012, Spain

Location

Miranza IOA

Madrid, 28033, Spain

Location

Clinicas Novovision - Clinica Madrid

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Aphakia; Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Project Lead, CRD Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: April 27, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)