Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

Recruiting

• Conditions: Glaucoma; Progression; Surgery

• Registration Number: NCT06174324
• Lead Sponsor: Klinikum Klagenfurt am Wörthersee

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2023-09-26
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual field progression (mean deviation, MD) 1 month postoperative, 3 months postoperative, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation.	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.
Intraocular pressure will be taken 1 month, 3 months, 6 months and 12 months after PreserFlo MicroShunt Implantation.	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.
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.	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.

Trial Locations

Locations (1)

KlinikumKlagenfurt; 🇦🇹 Klagenfurt, Austria