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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Open-angle Glaucoma
- Sponsor
- Healthguard Biomed
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with reduction of IOP greater than or equal to 20% compared to baseline in 12th month after surgery
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male of female, age 18 years or older
- •Mild to moderate open-angle glaucoma
- •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
Outcomes
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