Evaluation of Minimal Invasive Glaucoma Surgery

NCT ID: NCT04572880

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trabeculectomy

Group Type ACTIVE_COMPARATOR

Trabeculectomy

Intervention Type PROCEDURE

Trabeculectomy is performed

XEN®

Group Type ACTIVE_COMPARATOR

XEN®

Intervention Type DEVICE

Microinvasive Surgery with XEN® is performed

Preserflo®

Group Type ACTIVE_COMPARATOR

Preserflo®

Intervention Type DEVICE

Microinvasive Surgery with Preserflo® is performed

Interventions

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Trabeculectomy

Trabeculectomy is performed

Intervention Type PROCEDURE

XEN®

Microinvasive Surgery with XEN® is performed

Intervention Type DEVICE

Preserflo®

Microinvasive Surgery with Preserflo® is performed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Lindner Ewald, MD

Priv.-Doz. Dr.med.univ. Lindner Ewald

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Ewald Lindner, PD Dr.

Role: CONTACT

+43316385 ext. 80810

Facility Contacts

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Ewald Lindner

Role: primary

Other Identifiers

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1234567

Identifier Type: -

Identifier Source: org_study_id

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