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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-07-19

Brief Summary

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

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GELA

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

Group Type EXPERIMENTAL

GELA

Intervention Type DEVICE

GELA glaucoma implant

XEN

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

Group Type ACTIVE_COMPARATOR

XEN

Intervention Type DEVICE

XEN gel stent implant

Interventions

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GELA

GELA glaucoma implant

Intervention Type DEVICE

XEN

XEN gel stent implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No