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

Not Applicable

• Conditions: Cataract
• Interventions: Device: Cataract Surgery

• Registration Number: NCT04756908
• Lead Sponsor: FSV6, Ltd.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2020-10-08
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-16
• Status Verified: 2022-06
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifocal AIOL	Cataract Surgery	-
Monofocal AIOL	Cataract Surgery	-
Opira AIOL	Cataract Surgery	-

Primary Outcome Measures

Name	Time	Method
Adverse event rates	12 Months
Visual Acuity	6 Months

Trial Locations

Locations (2)

Clinica 2020; 🇨🇷 San José, Costa Rica

Codet Vision Institute; 🇲🇽 Tijuana, Mexico