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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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.
Time frame: 6 months
IOP reduction
The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.
Time frame: 6 months
topical IOP-lowering medications
Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.
Time frame: 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.
Time frame: 12 months
Adverse event
Adverse events was recorded and summarized.
Time frame: 12 months
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