Active — Not RecruitingNot Applicable

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

China207 participantsStarted 2022-10-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT06741774

SponsorHealthguard Biomed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-04

View on ClinicalTrials.gov More Open-angle Glaucoma trials