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NCT05892185 Clinical Trial

Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

Glaucoma Clinical Trial

Official title:
A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05892185
Other study ID # MC-001-081
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date July 19, 2024

Study information
Verified date May 2023
Source Mingche Biotechnology CO., LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date July 19, 2024
Est. primary completion date January 12, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GELA
GELA glaucoma implant
• XEN
XEN gel stent implant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mingche Biotechnology CO., LTD

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary IOP reduction The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group. 6 months
Secondary topical IOP-lowering medications Counting by class of drug of topical IOP lowering medications before and 6-month after surgery. 6 months
Secondary 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
Secondary Adverse event Adverse events was recorded and summarized. 12 months
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