Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )
NCT ID: NCT06741774
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
207 participants
INTERVENTIONAL
2022-10-19
2026-05-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System
Eyes with OAG and cataracts randomly divided into test group that were planned for combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System.
Trabecular Meshwork Microstent Drainage System
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.
phacoemulsification
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
phacoemulsification
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
Interventions
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Trabecular Meshwork Microstent Drainage System
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.
phacoemulsification
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma
18 Years
ALL
No
Sponsors
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Healthguard Biomed
INDUSTRY
Responsible Party
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Principal Investigators
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Xinghuai Sun, Doctor
Role: PRINCIPAL_INVESTIGATOR
EENT hospital of Fudan University
Locations
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Healthguard Biomed
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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HGB-CMP-TMS-001
Identifier Type: -
Identifier Source: org_study_id