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Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

NCT06174324 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

PreserFlo Microshunt

The PreserFlo MicroShunt was invented to create a minimally invasive glaucoma drainage device, that comes close to the eye pressure reduction and safety profile of the current gold standard, the trabeculectomy. Reference: Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, Palmberg P, Parrish RK 2nd, Weber BA, Kwon Y, Parel JM. The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl Biomater. 2017 Jan;105(1):211-221. doi: 10.1002/jbm.b.33525. Epub 2015 Sep 18. PMID: 26380916; PMCID: PMC5215625.

Sponsors & Collaborators

  • Medical University of Graz

    collaborator OTHER

  • Klinikum Klagenfurt am Wörthersee

    lead OTHER

Principal Investigators

  • Yosuf El-Shabrawi · Klinikum Klagenfurt am Wörthersee

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2024-09-09
Completion
2024-09-09
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174324 on ClinicalTrials.gov