Evaluation of Minimal Invasive Glaucoma Surgery

March 22, 2023 updated by: Lindner Ewald, MD, Medical University of Graz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trabeculectomy
Procedure: Trabeculectomy
Trabeculectomy is performed
Active Comparator: XEN®
Device: XEN®
Microinvasive Surgery with XEN® is performed
Active Comparator: Preserflo®
Device: Preserflo®
Microinvasive Surgery with Preserflo® is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intraocular pressure
Time Frame: up to 5 years post surgery
Goldmann Applanation Tonometry [mmHg]
up to 5 years post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of medications
Time Frame: up to 5 years post surgery
antihypertensive eye-drops
up to 5 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234567

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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