Trials / Not Yet Recruiting
Not Yet RecruitingNCT05364983
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- LensGen, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Juvene IOL | Cataract extraction and implantation of a posterior chamber IOL |
| DEVICE | Tecnis® Monofocal (ZCB00, PCB00 or DCB00) | Cataract extraction and implantation of a posterior chamber IOL |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2024-11-01
- Completion
- 2026-11-01
- First posted
- 2022-05-06
- Last updated
- 2023-03-09
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05364983. Inclusion in this directory is not an endorsement.