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

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

Detailed 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.

Official Title
-----------------
A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: GELA
* Device: XEN


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GELA<br>Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery) | Device: GELA<br>* GELA glaucoma implant<br>|
| Active Comparator: XEN<br>Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery). | Device: XEN<br>* XEN gel stent implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate at 6 months after surgery | Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 6 month after surgery. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction | The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group. | 6 months | 
| topical IOP-lowering medications | Counting by class of drug of topical IOP lowering medications before and 6-month after surgery. | 6 months | 
| Success rate 12 months after operation | Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 12 month after surgery. | 12 months | 
| Adverse event | Adverse events was recorded and summarized. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma Implant