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

NCT ID: NCT05130554

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-07
• Study Completion Date: 2022-09-30

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.

Conditions

Glaucoma; Glaucoma, Open-Angle; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XEN45

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

Group Type: EXPERIMENTAL

XEN45 gel stent implantation

Intervention Type: PROCEDURE

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.

Interventions

XEN45 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.

Intervention Type: PROCEDURE

Other Intervention Names

XEN

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingkai Lin, M.D,Ph.D

Role: STUDY_CHAIR

Zhognshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021KYPJ172

Identifier Type: -

Identifier Source: org_study_id