Trials / Completed
CompletedNCT05131087
A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- New World Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
Detailed description
CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cadence implant | CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach |
Timeline
- Start date
- 2020-10-08
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
- First posted
- 2021-11-23
- Last updated
- 2023-10-13
Locations
1 site across 1 country: Mexico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05131087. Inclusion in this directory is not an endorsement.