Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )
NCT06741774 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2024-12-19
Summary
It is a prospective, multicenter, randomized, open label, parallel controlled, superiority clinical trial that evaluate efficacy and safety of Trabecular Meshwork Microstent Drainage System in Reducing Intraocular Pressure in Adult Patients With Mild to Moderate Open-angle Glaucoma Combined With Cataract.
Conditions
- Open-angle Glaucoma
- Cataract
Interventions
- DEVICE
-
Trabecular Meshwork Microstent Drainage System
The device is implanted on the functional trabecular meshwork with head in schlemm canal and tail in anterior chamber. There is a hollow tube connecting schlemm canal and anterior chamber. The device can promote external drainage of aqueous humor to reduce intraocular pressure.
- PROCEDURE
-
phacoemulsification
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
Sponsors & Collaborators
-
Healthguard Biomed
lead INDUSTRY
Principal Investigators
-
Xinghuai Sun, Doctor · EENT hospital of Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-19
- Primary Completion
- 2025-12-04
- Completion
- 2026-05-04
Countries
- China
Study Locations
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