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

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: a Prospective, Multicenter, Randomized, Open Label, Parallel Controlled, Superiority Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract; Open-angle Glaucoma
• Intervention / Treatment: Device: Trabecular Meshwork Microstent Drainage System; Procedure: phacoemulsification

Detailed Description

The trial is a prospective, multicenter, randomized, open label, parallel controlled, superiority study. Eligible subjects will be randomly assigned to either test group or control group for treatment. The trial is divided into four research stages, with each subject expected to participate for maximum 14 months. The entire research phase includes:

Screening visit (V1, -60~-1 day). Baseline visit (V2). Randomization and surgery (V3): The subjects will be randomly assigned in 2:1 ratio to either test group (phacoemulsification with implantation of IOL combined with implantation of trabecular meshwork microstent drainage system) or control group (phacoemulsification with implantation of IOL only).

Follow-up visits (V4 ~ V10): different time points after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Healthguard Biomed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System; Eyes with OAG and cataracts randomly divided into test group that were planned for combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System.	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.; Other Names: combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System
Active Comparator: phacoemulsification; Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.	Procedure: phacoemulsification; Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Healthguard Biomed
• Investigators: Principal Investigator: Xinghuai Sun, Doctor, EENT hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Estimated): December 4, 2025
• Study Completion (Estimated): May 4, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: cataract; open-angle glaucoma; trabecular meshwork; IOP reduction; micro stent
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: HGB-CMP-TMS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No