A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens
Status: Not_yet_recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:
• Subjects must be 22 years of age or older
• Able to comprehend and provide written informed consent
• Willing and able to comply with schedule for follow-up visits
• Demonstrate sufficient cognitive awareness to comply with examination procedures
• Other inclusion criteria specified in the protocol may apply.
Contact Information
Primary
Patrick R Casey, O.D.
info@lensgen.com
(949) 472-5112
Time Frame
Start Date: 2023-05
Completion Date: 2026-11
Participants
Target number of participants: 56
Treatments
Experimental: Investigational IOL
Juvene® IOL
Active_comparator: Control IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Authors
Michael Bradley, Vance Thompson, Shamik Bafna, Majid Moshirfar, Albert Cheung, Elizabeth Yeu-Lin, John Berdahl, Mujtaba Qazi, Jay Pepose
Related Therapeutic Areas
Sponsors
Leads: LensGen, Inc.