The effect of the corneal endothelium using PreserFlow MicroShunt

The effect of the corneal endothelium using PreserFlow MicroShunt - The effect of the ECD using PFM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057723

Enrollment

Registered

2025-04-26

Start date

2022-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

glaucoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 34 cases that underwent PFM surgery at Fukui Saiseikai Hospital between December 2022 and November 2023.

Exclusion criteria

Exclusion criteria: The exclusion criteria included the presence of angle-closure glaucoma, secondary glaucoma, pediatric glaucoma, a history of glaucoma surgery (excluding laser treatment), vitrectomy, conjunctival incision-involving buckling surgery, uveitis, steroid use, trauma, ocular infections, inflammatory diseases, corneal diseases, and retinal diseases.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure was the change in endothelial cell density (ECD). ECD was measured preoperatively and at 12 months postoperatively using a specular microscope at three locations: the central cornea, the cornea proximal to the PFM, and the cornea distal to the PFM. The auto-center method was used for measurement (Supplemental figure 1). Preoperatively, only the central cornea was assessed, whereas at 12 months postoperatively, measurements were taken at the central cornea, PFM-proximal cornea, and PFM-distal cornea.	—

Measure

Time frame

The primary outcome measure was the change in endothelial cell density (ECD). ECD was measured preoperatively and at 12 months postoperatively using a specular microscope at three locations: the central cornea, the cornea proximal to the PFM, and the cornea distal to the PFM. The auto-center method was used for measurement (Supplemental figure 1). Preoperatively, only the central cornea was assessed, whereas at 12 months postoperatively, measurements were taken at the central cornea, PFM-proximal cornea, and PFM-distal cornea.

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Secondary

Measure	Time frame
As a secondary outcome measure, the insertion position of the PFM was evaluated using anterior segment optical coherence tomography (AS-OCT) at 12 months postoperatively. Based on the report by Tan et al., 23 three parameters were analyzed: the insertion angle between the cornea and the center of the tube (TA; Tube Angle), the distance between the cornea and the center of the tube (DT; Distance Tube), and the tube length inside the anterior chamber (TL; Tube Length).	—

Measure

Time frame

As a secondary outcome measure, the insertion position of the PFM was evaluated using anterior segment optical coherence tomography (AS-OCT) at 12 months postoperatively. Based on the report by Tan et al., 23 three parameters were analyzed: the insertion angle between the cornea and the center of the tube (TA; Tube Angle), the distance between the cornea and the center of the tube (DT; Distance Tube), and the tube length inside the anterior chamber (TL; Tube Length).

—

Countries

Japan

Contacts

Public ContactKoji Nitta

Fukui-ken Saiseikai Hospital Ophthalmology

nitta.koji7001@fukui.saiseikai.or.jp0776-23-1111

Outcome results