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

February 13, 2023 updated by: FSV6, Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
      • San José, Costa Rica
        • Recruiting
        • Clinica 2020
  • Mexico
      • Tijuana, Mexico
        • Recruiting
        • CODET Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Opira AIOL
Device: Cataract Surgery
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.
ACTIVE_COMPARATOR: Monofocal AIOL
Device: Cataract Surgery
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.
ACTIVE_COMPARATOR: Multifocal AIOL
Device: Cataract Surgery
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 6 Months
6 Months
Adverse event rates
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FSV6, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2020

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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