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

Not Applicable

Not yet recruiting

• Conditions: Glaucoma
• Interventions: Device: XEN; Device: GELA

• Registration Number: NCT05892185
• Lead Sponsor: Mingche Biotechnology CO., LTD

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study Start: 2023-05-31
• Study First Submitted QC: 2023-06-06
• Last Update Submitted: 2023-06-06
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07
• Primary Completion: 2024-01-12
• Study Completion: 2024-07-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Success rate at 6 months after surgery	6 months	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.

Secondary Outcome Measures

Name	Time	Method
IOP reduction	6 months	The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.
Adverse event	12 months	Adverse events was recorded and summarized.
topical IOP-lowering medications	6 months	Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.
Success rate 12 months after operation	12 months	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.