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

Healthguard Biomed

Status: Active, not recruiting

Conditions: Cataract; Open-angle Glaucoma

Treatments: Device: Trabecular Meshwork Microstent Drainage System; Procedure: phacoemulsification

Study type: Interventional

Funder types: Industry

Identifiers

NCT06741774

HGB-CMP-TMS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System

Experimental group

Description:

Eyes with OAG and cataracts randomly divided into test group that were planned for combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System.

Treatment:

Device: Trabecular Meshwork Microstent Drainage System

phacoemulsification

Active Comparator group

Description:

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

Treatment:

Procedure: phacoemulsification