A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
NCT05131087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-10-13
Summary
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
New World Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Mark Sun, PhD · New World Medical, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-08
- Primary Completion
- 2023-07-05
- Completion
- 2023-07-05
- FDA Device
- Yes
Countries
- Mexico
Study Locations
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