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

Recruiting
50 - 75 years of age
Both
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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

Eligibility

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

Study details

Cataract

NCT04756908

FSV6, Ltd.

27 January 2024

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