NCT05892185

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 23, 2023

Last Update Submit

June 6, 2023

Conditions

Glaucoma

Keywords

Glaucoma Implant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • IOP reduction

    6 months

  • topical IOP-lowering medications

    6 months

  • Success rate 12 months after operation

    12 months

  • Adverse event

    12 months

Study Arms (2)

GELA

EXPERIMENTAL

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

Device: GELA

XEN

ACTIVE COMPARATOR

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

Device: XEN

Interventions

GELADEVICE

GELA glaucoma implant

GELA
XENDEVICE

XEN gel stent implant

XEN

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 7, 2023

Study Start

May 31, 2023

Primary Completion

January 12, 2024

Study Completion

July 19, 2024

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share