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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Open-angle Glaucoma Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Lens Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthguard Biomed

Suzhou, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trabecular Meshwork Microstent Drainage System

Device

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

phacoemulsification

Procedure

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

Primary outcomes

Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery

Time frame: 12 months

IOP measured by Goldmann applanation tonometry

Sponsors and collaborators

Lead sponsor

Healthguard Biomed

Industry

Registry information

Official study title

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

Acronym: MicroCOGO

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Dec 19, 2024
Registry last updated: Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed