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

NCT06741774 | Active Not Recruiting

• 1 other identifier: HGB-CMP-TMS-001
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-angle Glaucoma; Cataract

Keywords

cataract; IOP reduction; open-angle glaucoma; trabecular meshwork; micro stent

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

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.

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.

Procedure: phacoemulsification

Interventions

Trabecular Meshwork Microstent Drainage System DEVICE

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.

Also known as: combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System

combined phacoemulsification and implantation of Trabecular Meshwork Microstent Drainage System

phacoemulsification PROCEDURE

Eyes with OAG and cataracts randomly divided into control group that were planned for phacoemulsification alone.

phacoemulsification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders
• Active corneal inflammation or edema
• Retinal disorders not associated with glaucoma

Sponsors & Collaborators

• Healthguard Biomed: lead

Study Sites (1)

Healthguard Biomed

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Xinghuai Sun, Doctor

  EENT hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 19, 2024
• Study Start: October 19, 2022
• Primary Completion: December 4, 2025
• Study Completion: May 4, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)