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Evaluation of Minimal Invasive Glaucoma Surgery

Primary Purpose

Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Trabeculectomy

XEN®

Preserflo®

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring MIGS, XEN®, Trabeculectomy, Preserflo®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Trabeculectomy

XEN®

Preserflo®

Arm Description

Outcomes

Primary Outcome Measures

Mean intraocular pressure

Goldmann Applanation Tonometry [mmHg]

Secondary Outcome Measures

Number of medications

antihypertensive eye-drops

Full Information

NCT ID

NCT04572880

First Posted

August 3, 2020

Last Updated

March 22, 2023

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT04572880

Brief Title

Evaluation of Minimal Invasive Glaucoma Surgery

Official Title

Evaluation of Minimal Invasive Glaucoma Surgery: Trabeculectomy vs. XEN ® vs. Preserflo ®. Randomized Clinial Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 21, 2021 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

150 Patients will be randomized to one of the 3 surgeries. Trabeculectomy Preserflo® or Xen® will be done according to a standard protocol Data will be collected for 5 years after surgery, Visual Acuity, Applanation Tonometry, Slit lamp Biomicroscopy, Endothelial cell cound, visual fields, optical coherence tomography of the optic disc, retina and anterior segment, impression cytology and life quality will be done on day of enrollment and during followup. Mean Intraocular pressure and number of glaucoma medications, Endothelial cell loss, visual acuity, visual fields and assessment of life quality will be assessed during the post-operative follow-ups at one week, one month, 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

MIGS, XEN®, Trabeculectomy, Preserflo®

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trabeculectomy

Arm Type

Active Comparator

Arm Title

XEN®

Arm Type

Active Comparator

Arm Title

Preserflo®

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Trabeculectomy

Intervention Description

Trabeculectomy is performed

Intervention Type

Device

Intervention Name(s)

XEN®

Intervention Description

Microinvasive Surgery with XEN® is performed

Intervention Type

Device

Intervention Name(s)

Preserflo®

Intervention Description

Microinvasive Surgery with Preserflo® is performed

Primary Outcome Measure Information:

Title

Mean intraocular pressure

Description

Goldmann Applanation Tonometry [mmHg]

Time Frame

up to 5 years post surgery

Secondary Outcome Measure Information:

Title

Number of medications

Description

antihypertensive eye-drops

Time Frame

up to 5 years post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ewald Lindner, PD Dr.

Phone

+43316385

Ext

80810

ewald.lindner@medunigraz.at

Facility Information:

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ewald Lindner

ewald.lindner@medunigraz.at

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Minimal Invasive Glaucoma Surgery

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