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

Last updated: February 13, 2023
Sponsor: FSV6, Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

N/A

Clinical Study ID

NCT04756908
CIP-04
  • Ages 50-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Comorbidities affecting visual acuity, IOP > 22mmHg, congential cataract

Study Design

Total Participants: 200
Study Start date:
October 08, 2020
Estimated Completion Date:
June 30, 2024

Study Description

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

Connect with a study center

  • Clinica 2020

    San José,
    Costa Rica

    Active - Recruiting

  • Codet Vision Institute

    Tijuana,
    Mexico

    Active - Recruiting

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