Open-angle GlaucomaMicroCOGONCT06741774
Efficacy and Safety of Trabecular Meshwork Microstent Drainage System ( MicroCOGO )
A study testing Trabecular Meshwork Microstent Drainage System and phacoemulsification in people with Open-angle Glaucoma and Cataract, run by Healthguard Biomed at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Cataract
- What is being tested?
- Trabecular Meshwork Microstent Drainage System and phacoemulsification
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 4 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
- Active corneal inflammation or edema
- Retinal disorders not associated with glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Open-angle Glaucoma, Cataract
- Being tested
- Trabecular Meshwork Microstent Drainage System, phacoemulsification
- Keywords
- cataract, IOP reduction, open-angle glaucoma, trabecular meshwork, micro stent
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular Meshwork Microstent Drainage SystemDevice
Also called combined phacoemulsification and implantation of 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.
phacoemulsificationProcedure or surgery
Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.
| Study group | Role | What they receive |
|---|---|---|
| combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System | Experimental | Eyes with OAG and cataracts randomly divided into test group that were planned for combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System. Receives: Device: Trabecular Meshwork Microstent Drainage System |
| phacoemulsification | Active comparator | Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone. Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start19 Oct 2022
- Primary completion4 Dec 2025 (estimated)
- Study completion4 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthguard Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghuai Sun, Doctor, Principal investigator, EENT hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741774
- Sponsor's protocol ID
- HGB-CMP-TMS-001
- Acronym
- MicroCOGO
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06741774
- Acronym / sponsor ID
- MicroCOGO / HGB-CMP-TMS-001
- Conditions
- Open-angle Glaucoma, Cataract
- Keywords
- cataract, IOP reduction, open-angle glaucoma, trabecular meshwork, micro stent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Healthguard BiomedIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 4 Dec 2025 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System | Experimental | Device: Trabecular Meshwork Microstent Drainage SystemEyes with OAG and cataracts randomly divided into test group that were planned for combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System. |
| phacoemulsification | Active comparator | Procedure: phacoemulsificationEyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
- Active corneal inflammation or edema
- Retinal disorders not associated with glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabecular Meshwork Microstent Drainage SystemAlso: combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage SystemThe 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. | Device | combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System |
| phacoemulsificationEyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone. | Procedure or surgery | phacoemulsification |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinghuai Sun, Doctor principal investigator
EENT hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabecular Meshwork Microstent Drainage System and phacoemulsification in people with Open-angle Glaucoma and Cataract, run by Healthguard Biomed at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.