Evaluation of Minimal Invasive Glaucoma Surgery

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04572880

Collaborator

(none)

150

Enrollment

Location

Arms

45.3

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Trabeculectomy Device: XEN® Device: Preserflo®	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 21, 2021

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean intraocular pressure [up to 5 years post surgery]
Goldmann Applanation Tonometry [mmHg]

Secondary Outcome Measures

Number of medications [up to 5 years post surgery]
antihypertensive eye-drops

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lindner Ewald, MD, Priv.-Doz. Dr.med.univ. Lindner Ewald, Medical University of Graz

ClinicalTrials.gov Identifier:

NCT04572880

Other Study ID Numbers:

1234567

First Posted:

Oct 1, 2020

Last Update Posted:

Jan 13, 2022

Last Verified:

Dec 1, 2021

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

Keywords provided by Lindner Ewald, MD, Priv.-Doz. Dr.med.univ. Lindner Ewald, Medical University of Graz

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Jan 13, 2022