NCT06741774

Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( 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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: Healthguard Biomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Open-angle Glaucoma
• Cataract

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-12-04
• Completion: 2026-05-04
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China