Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
Sponsor
FSV6, Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04756908
Collaborator
(none)
200
2
3
43.8
100
2.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
Anticipated 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
:
Oct 8, 2020
Anticipated Primary Completion Date
:
Jan 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2024
Arms and Interventions
| 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
Primary Outcome Measures
- Visual Acuity [6 Months]
- Adverse event rates [12 Months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica 2020 | San José | Costa Rica | ||
| 2 | Codet Vision Institute | Tijuana | Mexico |
Sponsors and Collaborators
- FSV6, Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
FSV6, Ltd.
ClinicalTrials.gov Identifier:
NCT04756908
Other Study ID Numbers:
- CIP-04
First Posted:
Feb 16, 2021
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: