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NCT04756908 Clinical Trial

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

Cataract Clinical Trial

Official title:
Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, A Commercial Multifocal IOL, and a Commercial Monofocal IOL

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04756908
Other study ID # CIP-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2020
Est. completion date June 2024

Study information
Verified date June 2022
Source FSV6, Ltd.
Contact Paul Rhee, O.D
Phone 9492944191
Email prhee@forsightv6.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Cataract Surgery
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

Locations
Country Name City State
Costa Rica Clinica 2020 San José
Mexico Codet Vision Institute Tijuana

Sponsors (1)
Lead Sponsor Collaborator
FSV6, Ltd.

Countries where clinical trial is conducted

Costa Rica,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity 6 Months
Primary Adverse event rates 12 Months
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