Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

Last updated: December 15, 2023
Sponsor: Klinikum Klagenfurt am Wörthersee
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Surgery

Treatment

PreserFlo Microshunt

Clinical Study ID

NCT06174324
S2021-29
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with insufficient eye pressure control despite IOP (intraocularpressure)-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

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: PreserFlo Microshunt
Phase:
Study Start date:
October 12, 2021
Estimated Completion Date:
September 09, 2024

Connect with a study center

  • KlinikumKlagenfurt

    Klagenfurt, 9020
    Austria

    Active - Recruiting

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