Back to resultsEvaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma
Primary Purpose
Glaucoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GELA
XEN
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma Implant
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GELA
XEN
Arm Description
Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery)
Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
IOP reduction
The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.
topical IOP-lowering medications
Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.
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.
Adverse event
Adverse events was recorded and summarized.
Full Information
NCT ID
NCT05892185
First Posted
May 23, 2023
Last Updated
June 6, 2023
Sponsor
Mingche Biotechnology CO., LTD
1. Study Identification
Unique Protocol Identification Number
NCT05892185
Brief Title
Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma
Official Title
A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
July 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mingche Biotechnology CO., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GELA
Arm Type
Experimental
Arm Description
Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery)
Arm Title
XEN
Arm Type
Active Comparator
Arm Description
Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery).
Intervention Type
Device
Intervention Name(s)
GELA
Intervention Description
GELA glaucoma implant
Intervention Type
Device
Intervention Name(s)
XEN
Intervention Description
XEN gel stent implant
Primary Outcome Measure Information:
Title
Success rate at 6 months after surgery
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
IOP reduction
Description
The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.
Time Frame
6 months
Title
topical IOP-lowering medications
Description
Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.
Time Frame
6 months
Title
Success rate 12 months after operation
Description
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.
Time Frame
12 months
Title
Adverse event
Description
Adverse events was recorded and summarized.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma
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