Glaucoma
Conditions
Keywords
Glaucoma Implant
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.
Interventions
DEVICEGELA
GELA glaucoma implant
DEVICEXEN
XEN gel stent implant
Sponsors
Mingche Biotechnology CO., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| IOP reduction | 6 months | The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group. |
| 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. |
| Adverse event | 12 months | Adverse events was recorded and summarized. |
Outcome results
None listed