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

NCT05130554 | Unknown

• 1 other identifier: 2021KYPJ172
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Glaucoma, Open-Angle; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• anti-glaucoma drugs changes

  Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery

• IOP (intraocular pressure) changes

  Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery

Study Arms (1)

XEN45

EXPERIMENTAL

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

Procedure: XEN45 gel stent implantation

Interventions

XEN45 gel stent implantation 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.

Also known as: XEN

XEN45

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with POAG;
• The visual acuity of the affected eye is greater than that of manual operation;
• Between 18 and 90 years old;
• No surgery or laser treatment within 90 days;
• Patients with other types of glaucoma whose intraocular pressure has not been controlled by traditional surgery or medication;
• The target quadrant has healthy conjunctiva and free movement without scars.

You may not qualify if:

• Angle-closure glaucoma;
• Active uveitis;
• Any corneal disease;
• Patients with eye infections two weeks before the operation;
• During pregnancy or lactation;
• Active neovascular glaucoma;
• Known or suspected allergy or sensitivity to pig products or glutaraldehyde.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Allergan: collaborator

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Mingkai Lin, M.D,Ph.D

  Zhognshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: November 23, 2021
• Study Start: November 7, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)