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The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GELA | Experimental | Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery) |
|
| XEN | Active Comparator | Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GELA | Device | GELA glaucoma implant |
| |
| XEN |
| 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 |
| 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. |
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Inclusion Criteria
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Device |
XEN gel stent implant |
|
| 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 |