Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )

NCT06741774 · tracked via the Priya Life Science China tracker

Sponsor

Healthguard Biomed

Phase

Not applicable

Started

2022-10-19

Last updated

2024-12-19

Condition(s) studied

Open-angle GlaucomaCataract

Investigational drug(s) / intervention(s)

Trabecular Meshwork Microstent Drainage Systemphacoemulsification

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.

phacoemulsification: Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male of female, age 18 years or older * Mild to moderate open-angle glaucoma * Cataract * Average of IOP is less than or equal to 24mmHg with 1-3 drugs in the screening period * All 3 diurnal IOPs after drug-eluting are greater than 21mmHg and less than or equal to 35mmHg, average of diurnal IOPs is at least 3.0mmHg higher than the pre drug-eluting IOP * Cup to disc ratio (C/D) less than or equal to 0.8, or VFI greater than 75% * Gonioscope shows that anterior chamber angle is open Exclusion Criteria: * Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma

Primary outcome measure(s)

Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery — 12 months
IOP measured by Goldmann applanation tonometry

Trial sites (1)

Facility	City	Region	Status
Healthguard Biomed	Suzhou	Jiangsu

Other trials for the same condition

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Visual Quality of Cataract Patients with High Myopia After Implantation of Different Intraocular Lenses Active, not recruiting

Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs Recruiting

Comparison of Early Postoperative Visual Acuity Between Intracapsular and Supracapsular Phacoemulsification: A Randomized Controlled Clinical Trial Starting soon

D615L vs Zeiss 839MP: Visual Quality Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06741774 on ClinicalTrials.gov ↗ ← All trials in China