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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04756908
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
FSV6, Ltd.

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

Condition or disease Intervention/treatment Phase
Cataract Device: Cataract Surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, A Commercial Multifocal IOL, and a Commercial Monofocal IOL
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 6 Months ]
  2. Adverse event rates [ Time Frame: 12 Months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04756908


Contacts
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Contact: Paul Rhee, O.D 9492944191 prhee@forsightv6.com

Locations
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Costa Rica
Clinica 2020 Not yet recruiting
San José, Costa Rica
Contact: Nadja Dodero         
Mexico
Codet Vision Institute Recruiting
Tijuana, Mexico
Contact: Martha Federico         
Sponsors and Collaborators
FSV6, Ltd.
More Information
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Responsible Party: FSV6, Ltd.
ClinicalTrials.gov Identifier: NCT04756908    
Other Study ID Numbers: CIP-04
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases