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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
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.
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
Healthguard Biomed
Suzhou, Jiangsu, China
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
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.