XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

Sun Yat-sen University

Status: Unknown

Conditions: Surgery; Glaucoma; Glaucoma, Open-Angle

Treatments: Procedure: XEN45 gel stent implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05130554

2021KYPJ172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

XEN45

Experimental group

Description:

The effect of XEN45 surgery on patients with primary open-angle glaucoma

Treatment:

Procedure: XEN45 gel stent implantation