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

Last updated: March 11, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Presbyopia

Astigmatism

Treatment

AcrySof IQ PanOptix Toric IOL

AcrySof IQ PanOptix IOL

Clinical Study ID

NCT06166901
ILH297-I001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject or legally authorized representative must be able to understand and sign anInstitutional Review Board (IRB)/Independent Ethics Committee (IEC) approvedinformed consent form.

  • Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySofPanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have aToric lens in one eye and a non-Toric in the fellow eye.

  • Subject must have a documented medical history and required pre-operative baselineinformation available for retrospective data collection.

Exclusion

Exclusion Criteria:

  • Subject currently participating in another investigational drug or device study.

  • Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySofPanOptix Toric IOL implantation.

  • Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that havesubsequently undergone an IOL exchange and are no longer implanted with a study IOLat the time of enrollment.

  • Subject is pregnant or nursing at the time of enrollment.

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: AcrySof IQ PanOptix Toric IOL
Phase:
Study Start date:
April 27, 2024
Estimated Completion Date:
February 05, 2025

Study 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.

Connect with a study center

  • Hospital Universitari General de Catalunya

    Sabadell, Barcelona 8205
    Spain

    Site Not Available

  • Oftalvist Jerez - HLA Puerta del Sur

    Jerez De La Frontera, Cadiz 11408
    Spain

    Site Not Available

  • Barraquer Ophthalmology Center

    Barcelona, 08021
    Spain

    Site Not Available

  • Institut Catala de la Retina - Sarria

    Barcelona, 8022
    Spain

    Site Not Available

  • Hospital Arruzafa

    Cordoba, 14012
    Spain

    Site Not Available

  • Clinicas Novovision - Clinica Madrid

    Madrid, 28046
    Spain

    Site Not Available

  • Miranza IOA

    Madrid, 28033
    Spain

    Site Not Available

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