NCT04572880

Brief Summary

Glaucoma is a neurodegenerative disease with an accelerated and progressiv retinal ganglion cell loss and concomitant visual field defects. Glaucoma can be treated with eye drops, laser therapy or surgery. Various surgical approaches to lower intraocular pressure are available, amongst which trabeculectomy is the gold standard. Recently minimal invasive glaucoma surgery has been introduced and has become a good alternative to trabeculectomy. Randomized clinical trials investigating the postoperative outcomes of various types of glaucoma surgery are limited.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

August 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

August 3, 2020

Last Update Submit

March 22, 2023

Conditions

Glaucoma

Keywords

MIGSXEN®TrabeculectomyPreserflo®

Outcome Measures

Primary Outcomes (1)

  • Mean intraocular pressure

    Goldmann Applanation Tonometry \[mmHg\]

    up to 5 years post surgery

Secondary Outcomes (1)

  • Number of medications

    up to 5 years post surgery

Study Arms (3)

Trabeculectomy

ACTIVE COMPARATOR
Procedure: Trabeculectomy

XEN®

ACTIVE COMPARATOR
Device: XEN®

Preserflo®

ACTIVE COMPARATOR
Device: Preserflo®

Interventions

TrabeculectomyPROCEDURE

Trabeculectomy is performed

Trabeculectomy
XEN®DEVICE

Microinvasive Surgery with XEN® is performed

XEN®
Preserflo®DEVICE

Microinvasive Surgery with Preserflo® is performed

Preserflo®

Eligibility Criteria

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

You may qualify if:

  • Patiens with glaucoma in which surgery is indicated to reach target intraocular pressure
  • Subjects not anticipated to require any further surgery in the next 12 months

You may not qualify if:

  • Patients who do not want to make follow-ups at the department
  • angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, Axenfeld-Rieger syndrom.
  • Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
  • Any major ocular inflammation up to 30 days prior to surgery
  • Conjunctival scarring
  • Allergy to any drugs required for the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Ewald Lindner, PD Dr.

CONTACT

+43316385ewald.lindner@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr.med.univ. Lindner Ewald

Study Record Dates

First Submitted

August 3, 2020

First Posted

October 1, 2020

Study Start

December 21, 2021

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

AU(1)