Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

Mingche Biotechnology

Status: Not yet enrolling

Conditions: Glaucoma

Treatments: Device: GELA; Device: XEN

Study type: Interventional

Funder types: Industry

Identifiers

NCT05892185

MC-001-081

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.

Full description

A prospective, randomized, single-blind, positive control design was used to study primary open-angle glaucoma. Eligible subjects were screened and randomly assigned to the experimental group and the control group.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

GELA

Experimental group

Description:

Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery)

Treatment:

Device: GELA

XEN

Active Comparator group

Description:

Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery).

Treatment:

Device: XEN