NCT05892185
Not yet recruiting
Not Applicable
A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.
Mingche Biotechnology CO., LTD0 sites20 target enrollmentMay 31, 2023
ConditionsGlaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Mingche Biotechnology CO., LTD
- Enrollment
- 20
- Primary Endpoint
- Success rate at 6 months after surgery
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Success rate at 6 months after surgery
Time Frame: 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 Outcomes
- Adverse event(12 months)
- IOP reduction(6 months)
- topical IOP-lowering medications(6 months)
- Success rate 12 months after operation(12 months)
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