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Efficacy and Safety of Stent assisted Liang’s Internal drainage Trabecular Surgery:A prospective, randomized, positive parallel-controlled, open-label, multicenter, clinical trial

Efficacy and Safety of Stent assisted Liang’s Internal drainage Trabecular Surgery:A prospective, randomized, positive parallel-controlled, open-label, multicenter, clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068827
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma

Interventions

group1:Stent assisted Liangs Internal drainage Trabecular Surgery
group2:Microcatheter-assisted circumferential trabeculotomy

Sponsors

TONGJI HOSPITAL TONGJI MEDICAL COLLEGE OF HUST
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)aged 18 to 75 years old (2)Patients with open-angle glaucoma with glaucoma medications or not with IOP > 21 mmHg; (3)Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) axis length 28mm; (2) BCVA of enrolled eye or contralateral eye <0.05; (3) with obvious cataract that is expected to undergo cataract surgery within 1 year (4) Patients with malignant glaucoma, active intraocular inflammation (such as uveitis glaucoma, etc.), neovascular glaucoma, glaucoma with elevated episcleral venous pressure, and glaucoma secondary to malignant tumors; (5) Patients with a condition that affects the reliability of IOP measurement such as thyroid associated ophthalmopathy; (6) Patients with a history of intraocular surgery (LPI laser iridoplasty and cataract surgery excepted) or conjunctival surgery such as gizzard excision with upper conjunctival transplant transplantation; (7)Patients with a history of allergy to anesthetic drugs or nitinol; (8)Patients with corneal dystrophy, active corneal inflammation, or ocular tumors; (9)Patients with Corneal endothelial cell density<800/mm2; (10)unable to cooperate with the examination, such as those with mental illness; (11)Pregnant and lactating women; (12)Have participated in other clinical trials within 30 days prior to this enrollment and may affect the evaluation of this clinical trial; (13)Other situations in which the investigator deemed inappropriate to participate in this trial;

Design outcomes

Primary

MeasureTime frame
IOP at postoperative 6 months;

Secondary

MeasureTime frame
qualified success rate at 6 months;complete success rate at 6 months;IOP reduction;number of glaucoma medications;Corneal endothelial cell loss rate;corneal thickness;uncorrected visual acuity;BCVA;

Countries

China

Contacts

Public ContactHong Zhang

TONGJI HOSPITAL TONGJI MEDICAL COLLEGE OF HUST

dr_zhanghong@vip.163.com+86 139 7167 9079

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026