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

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
FSV6, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica 2020Recruiting
  • Codet Vision InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Opira AIOL

Monofocal AIOL

Multifocal AIOL

Arm Description

Outcomes

Primary Outcome Measures

Visual Acuity
Adverse event rates

Secondary Outcome Measures

Full Information

First Posted
February 12, 2021
Last Updated
February 13, 2023
Sponsor
FSV6, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04756908
Brief Title
Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
Official Title
Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, A Commercial Multifocal IOL, and a Commercial Monofocal IOL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FSV6, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opira AIOL
Arm Type
Experimental
Arm Title
Monofocal AIOL
Arm Type
Active Comparator
Arm Title
Multifocal AIOL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Cataract Surgery
Intervention Description
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.
Primary Outcome Measure Information:
Title
Visual Acuity
Time Frame
6 Months
Title
Adverse event rates
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Rhee, O.D
Phone
9492944191
Email
prhee@forsightv6.com
Facility Information:
Facility Name
Clinica 2020
City
San José
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadja Dodero
First Name & Middle Initial & Last Name & Degree
C Orlich, MD
Facility Name
Codet Vision Institute
City
Tijuana
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Federico

12. IPD Sharing Statement

Learn more about this trial

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

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