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Completed

NCT Number: NCT06166901

Evaluation of Long-term Safety and Performance of PanOptix Trifocal 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.

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Key information

Conditions

Aphakia Astigmatism Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari General de Catalunya, Sabadell, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60

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.

Other names: Model TFNT00

Primary outcomes

  1. Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

    Time frame: Year 3-5 postoperative (Visit 1, Day 1)

    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.

  2. Number of Eyes Experiencing an Ocular Adverse Event by Toricity

    Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

    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.

  3. Number of Subjects Experiencing a Non-Ocular Adverse Event

    Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

    AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).

  4. Number of Device Deficiencies by Toricity

    Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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