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

Not Applicable

• Conditions: Glaucoma, Open-Angle; Glaucoma; Surgery
• Interventions: Procedure: XEN45 gel stent implantation

• Registration Number: NCT05130554
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-06
• Study Start: 2021-11-07
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XEN45	XEN45 gel stent implantation	The effect of XEN45 surgery on patients with primary open-angle glaucoma

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China