Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

  • End date
    Jun 15, 2024
  • participants needed
  • sponsor
    FSV6, Ltd.
Updated on 15 June 2022
intraocular lens implantation
bilateral cataracts


This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.


This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Condition Cataract
Treatment cataract surgery
Clinical Study IdentifierNCT04756908
SponsorFSV6, Ltd.
Last Modified on15 June 2022


Yes No Not Sure

Inclusion Criteria

Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity

Exclusion Criteria

Comorbidities affecting visual acuity, IOP > 22mmHg, congential cataract
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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