Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

December 15, 2023 updated by: Yosuf El-Shabrawi, Klinikum Klagenfurt am Wörthersee

Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation - a Prospective Cohort Study at the Ophthalmology Department Klinikum Klagenfurt

The trabeculectomy is the gold standard in glaucoma surgery, nevertheless often postoperative interventions have to be done. (1),(2) The PreserFlo MicroShunt (Santen, Osaka, Japan) implantation occurs without critical steps of trabeculectomy. (3) According to a study a 20% eye pressure reduction was achieved in 53.9% of patients one year after PreserFlo MicroShunt implantation and the risk of postoperative hypotony was clearly minimized. (4) It has been shown that after trabeculectomy there is a stable development of visual fields in the first 3 months after surgery and then, despite adequate intraocular pressure reduction, visual fields deteriorate. (5) At the Klinikum Klagenfurt structural and functional changes after PreserFlo MicroShunt Implantation shall be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Austria
      • Klagenfurt, Austria, 9020
        • Recruiting
        • KlinikumKlagenfurt
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with insufficient eye pressure control despite IOP-lowering therapy and the diagnosis of glaucoma

Description

Inclusion Criteria:

  • Patients with insufficient eye pressure control despite IOP (intraocular pressure)-lowering therapy
  • Diagnosis of POAG (primary open angle glaucoma)
  • Diagnosis of PEG (pseudoexfoliation glaucoma)
  • Diagnosis of PDG (pigment dispersion glaucoma)
  • Diagnosis of NTG (normal tension glaucoma)
  • Agreement of patients to participate in the study

Exclusion Criteria:

  • Previous glaucoma surgery
  • Visual acuity of Nulla Lux
  • Poor general condition
  • Pregnancy
  • Exudative macular degeneration

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual field progression (mean deviation, MD) 1 month postoperative, 3 months postoperative, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation.
Time Frame: Visual fields taken at baseline should be compared to visual fields 1 month postoperativ, 3 months postoperative and 1 year postoperative.
Visual fields of patients at baseline preoperative and 1 month postoperative, 3 months postoperative, 6 months postoperative and 12 months postoperative should be compared.
Visual fields taken at baseline should be compared to visual fields 1 month postoperativ, 3 months postoperative and 1 year postoperative.
RNFL (retinal nerve fiber layer) at baseline before sugery and changes after1 month, 3 months, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation will be evaluated.
Time Frame: The measurement of the nerve fiber index shall be done at baseline before surgery and 1 month, 3 months, 6 months and 12 months after surgery.
The measurement of the nerve fiber will be compared at baseline before surgery to the values at 1 month, 3 months, 6 months and 12 months after surgery.
The measurement of the nerve fiber index shall be done at baseline before surgery and 1 month, 3 months, 6 months and 12 months after surgery.
Intraocular pressure will be taken 1 month, 3 months, 6 months and 12 months after PreserFlo MicroShunt Implantation.
Time Frame: The intraocular pressure will be taken postoperative after one month, 3 months, 6 months and 12 months.
The evaluation of the intraocular pressure shall be done 1 month, 3 months, 6 months and 12 months after surgery.
The intraocular pressure will be taken postoperative after one month, 3 months, 6 months and 12 months.

Collaborators and Investigators

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

Sponsor

Klinikum Klagenfurt am Wörthersee

Collaborators

Medical University of Graz

Investigators

  • Principal Investigator: Yosuf El-Shabrawi, Klinikum Klagenfurt am Wörthersee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 12, 2021

Primary Completion (Estimated)

September 9, 2024

Study Completion (Estimated)

September 9, 2024

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2021-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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