Glaucoma, Glaucoma, Open-Angle, Surgery
Conditions
Brief summary
Glaucoma is the second most common blindness disease in the world, second only to cataracts. The current treatment of glaucoma is mainly to reduce intraocular pressure.At present, two commonly used surgical methods are trabeculectomy and implantation of drainage valve. These methods are superior to drug treatment in reducing intraocular pressure, but the effect duration of these two methods is not long, and there may be serious complications and failure. Compared with traditional glaucoma surgery, MIGS may have better safety.The XEN45 gel implant is a collagen tube with a length of 6 mm and a diameter of 45 µm, which creates a new channel for drainage of aqueous humor by connecting the anterior chamber and the subconjunctival space. The implant is composed of porcine gelatin cross-linked with glutaraldehyde, and has good biocompatibility and tolerance. Therefore, after the advent of XEN45 products, more and more studies have shown that this treatment has excellent safety and effectiveness in reducing intraocular pressure in patients with open-angle glaucoma. Considering that the XEN45 gel stent has been in the market for a relatively short time, we conducted this prospective study to investigate the effect of XEN45 surgery in the treatment of primary open-angle glaucoma, in order to support ophthalmologists in formulating the best surgical plan for patients. The promotion of this surgical method.
Detailed description
Observation index： The visual acuity, intraocular pressure, slit lamp, ophthalmoscope, traditional vision, UBM and anti-glaucoma drugs before surgery and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.
Interventions
PROCEDUREXEN45 gel stent implantation
The XEN45 gel implant is a collagen tube with a length of 6 mm and a diameter of 45 µm, which creates a new channel for drainage of aqueous humor by connecting the anterior chamber and the subconjunctival space. The implant is composed of porcine gelatin cross-linked with glutaraldehyde, and has good biocompatibility and tolerance.This treatment method has excellent safety and effectiveness in reducing the intraocular pressure of patients with open-angle glaucoma. At the same time, the operation is simple and safe.
Sponsors
Allergan
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with POAG; 2. The visual acuity of the affected eye is greater than that of manual operation; 3. Between 18 and 90 years old; 4. No surgery or laser treatment within 90 days; 5. Patients with other types of glaucoma whose intraocular pressure has not been controlled by traditional surgery or medication; 6. The target quadrant has healthy conjunctiva and free movement without scars.
Exclusion criteria
1. Angle-closure glaucoma; 2. Active uveitis; 3. Any corneal disease; 4. Patients with eye infections two weeks before the operation; 5. During pregnancy or lactation; 6. Active neovascular glaucoma; 7. Known or suspected allergy or sensitivity to pig products or glutaraldehyde.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP (intraocular pressure) changes | 3 months after surgery | Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP\> 21 mmHg and maximum tolerance of the drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA（Best corrected vision ability）changes | Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery | Evaluate the patient's BCVA changes before and after surgery |
| anti-glaucoma drugs changes | Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery | Compare the amount of patient's anti-glaucoma drugs before and after surgery |
| IOP (intraocular pressure) changes | Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery | Compare the patient's IOP changes before and after surgery. Complete success of the operation was defined as IOP≤21mmhg without any glaucoma drugs. Qualified success is defined as the same intraocular pressure level but with medication. Failure is defined as IOP\> 21 mmHg and maximum tolerance of the drug |
Countries
China
Outcome results
None listed