Status:
UNKNOWN
Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
Lead Sponsor:
FSV6, Ltd.
Conditions:
Cataract
Eligibility:
All Genders
50-75 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity
Exclusion
- Comorbidities affecting visual acuity, IOP \> 22mmHg, congential cataract
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04756908
Start Date
October 8 2020
End Date
June 1 2024
Last Update
February 14 2023
Active Locations (2)
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1
Clinica 2020
San José, Costa Rica
2
Codet Vision Institute
Tijuana, Mexico