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One-Year Efficacy of PreserFlo MicroShunt Implantation Across Glaucoma Severity Levels: A Multicenter Cohort Study

One-Year Efficacy of PreserFlo MicroShunt Implantation Across Glaucoma Severity Levels: A Multicenter Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260623001
Enrollment
150
Registered
2026-06-23
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, a chronic progressive optic neuropathy causing irreversible vision loss, in patients undergoing PreserFlo MicroShunt implantation to lower intraocular pressure across varying disease severities. PreserFlo MicroShunt Glaucoma surgery Minimally Invasive Bleb Surgery (MIBS) Glaucoma severity Surgical outcome

Interventions

Patients classified with Mild Glaucoma pre-operatively based on a reliable Standard Automated Perimetry (SAP) mean deviation (MD) value greater than -6.00 dB (Hodapp-Anderson-Parrish staging). For pat
Treatment,Treatment,Treatment
Mild Glaucoma,Moderate glaucoma,Severe glaucoma

Sponsors

Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older with a diagnosis of glaucoma. 2. Patients with a clinical indication for PreserFlo MicroShunt implantation, either as a standalone procedure or combined with cataract surgery. 3. Patients who underwent surgery at participating hospitals or medical centers, performed by glaucoma specialists involved in this study.

Exclusion criteria

Exclusion criteria: 1. Eyes with a history of previous complicated cataract surgery. 2. Patients with ocular or systemic conditions that may affect vision or visual field testing results, such as advanced diabetic retinopathy, retinal degeneration, cerebrovascular disease, or neuromuscular disorders. 3. Patients who were unable to complete the scheduled postoperative follow-up visits.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure At 12 months post PreserFlo MicroShunt Implantation Goldmann applanation tonometer

Secondary

MeasureTime frame
Visual Field (Median Deviation (dB), Pattern Standard deviation (dB), Visual Field Index (%) Within one year after PreserFlo MicroShunt Implantation A Humphrey visual field,Best-Corrected Visual Acuity (logMAR) Within one year after PreserFlo MicroShunt Implantation Snellen chart,Number of topical antiglaucoma medications Within one year after PreserFlo MicroShunt Implantation Out-Patient Department Record,Vertical cup-to-disc ratio Within one year after PreserFlo MicroShunt Implantation Slit lamp examination,RNFL Thickness (Average, Superior, Inferior, Nasal, Temporal) Within one year after PreserFlo MicroShunt Implantation Optical Coherence Tomography Printout,Lens status (phakia/pseudophakia/Aphakia) Within one year after PreserFlo MicroShunt Implantation Out-Patient Department Record,Preserflo Surgery Method Within one year after PreserFlo MicroShunt Implantation Operative note,Complication Operative note Out-Patient Department Record/,Post operative bleb needling +/- antimetabolite Within one year after PreserFlo MicroShunt Implantation Out-Patient Department Record,Endothelial Cell Density Within one year after PreserFlo MicroShunt Implantation Specular microscopy

Countries

Thailand

Contacts

Public ContactKitiya Ratanawongphaibul

Center of Excellence in Glaucoma, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

kitiyaoph@gmail.com6622564142

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026