Clinical trial NCT05130554: XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Official title: XEN45 in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Surgery
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2021-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: IOP (intraocular pressure) changes
timeFrame: 3 months after surgery
Secondary outcomes:
measure: BCVA（Best corrected vision ability）changes
timeFrame: Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
measure: anti-glaucoma drugs changes
timeFrame: Baseline (before surgery) and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
measure: IOP (intraocular pressure) changes
timeFrame: Baseline (before surgery) and 1 day, 1 week, 1 month,6 month and 12 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Mingkai Lin, M.D,Ph.D
role: STUDY_CHAIR
References: