open-angle glaucoma
Conditions
Interventions
Experimental group:Glaucoma drainage tube
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18= age =80 years old, gender is not limited; 2) Patients with open-angle glaucoma who are ineffective/intolerant (IOP still >21mmHg) after treatment with IOP lowering drugs; 3) The central thickness of the cornea is between 450-620µm; 4) Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent Patients being followed up.
Exclusion criteria
Exclusion criteria: 1) Participants suffer from neovascular glaucoma and uveitis glaucoma; 2) Eye inflammation or infection (such as blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) within 30 days prior to preoperative examination; 3) Patients with anterior chamber intraocular lens or vitreous prolapse; 4) Patients who have undergone vitreoretinal surgery within 3 months prior to surgery; 5) Patients who have undergone glaucoma surgery or conjunctival surgery in the past and have a conjunctival integrity of less than 180 degrees in the planned surgical area; 6) Expected need for combined glaucoma surgery or additional ophthalmic surgery or retinal laser surgery; 7) Patients with BCVA below 20/80 have an average visual field deviation of -18.0 decibels; 8) Patients with corneal endothelial cell density below 800/mm2; 9) Intraocular silicone oil, active diabetes retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion or other ophthalmic diseases that may affect the research results; 10) Patients with severe liver and kidney dysfunction (ALT or AST>3 times the upper limit of normal; serum creatinine>1.5 times the upper limit of normal); 11) Individuals known to be allergic to the components of experimental equipment or anesthetics; 12) Patients with systemic immune system diseases, scar constitution, tumor patients undergoing radiotherapy and chemotherapy, and patients with severe complications of diabetes; 13) Women who are pregnant, breastfeeding, or have a pregnancy plan during the study period; 14) Participants in clinical trials of other ophthalmic medical devices within 3 months prior to the screening period; 15) There are other surgical contraindications or situations that researchers believe cannot be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conditional success rate 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| time of operation;Conditional success rate 6 months after surgery;The complete success rate at 6 months and 12 months after surgery;The mean decrease of IOP from baseline to 6 and 12 months after surgery;Types of medications used to lower eye pressure;Instrument performance index;Incidence of device defect;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactChun Zhang
Peking University Third Hospital
Outcome results
None listed