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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05130554
• Other study ID #: 2021KYPJ172
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2021
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP (intraocular pressure) changes	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	3 months after surgery
Secondary	BCVA(Best corrected vision ability)changes	Evaluate the patient's BCVA changes before and after surgery	Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
Secondary	anti-glaucoma drugs changes	Compare the amount of patient's anti-glaucoma drugs before and after surgery	Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
Secondary	IOP (intraocular pressure) changes	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	Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery