Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

Klinikum Klagenfurt am Wörthersee

Status: Enrolling

Conditions: Surgery; Glaucoma; Progression

Treatments: Device: PreserFlo Microshunt

Study type: Observational

Funder types: Other

Identifiers

NCT06174324

S2021-29

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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