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

Sponsor
Mingche Biotechnology CO., LTD (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05892185
Collaborator
(none)
20
Enrollment
2
Arms
13.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GELA
  • Device: XEN
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.
Anticipated Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
Jan 12, 2024
Anticipated Study Completion Date :
Jul 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: GELA

Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery)

Device: GELA
GELA glaucoma implant
Active Comparator: XEN

Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery).

Device: XEN
XEN gel stent implant

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. IOP reduction [6 months]

    The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.

  2. topical IOP-lowering medications [6 months]

    Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.

  3. 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.

  4. Adverse event [12 months]

    Adverse events was recorded and summarized.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mingche Biotechnology CO., LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mingche Biotechnology CO., LTD
ClinicalTrials.gov Identifier:
NCT05892185
Other Study ID Numbers:
  • MC-001-081
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mingche Biotechnology CO., LTD
Glaucoma Implant
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Jun 7, 2023