UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057723 |
|---|---|
| Receipt number | R000065959 |
| Scientific Title | The effect of the corneal endothelium using PreserFlow MicroShunt |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2025/04/25 17:11:32 |
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Basic information
Public title
The effect of the corneal endothelium using PreserFlow MicroShunt
Acronym
The effect of the ECD using PFM
Scientific Title
The effect of the corneal endothelium using PreserFlow MicroShunt
Scientific Title:Acronym
The effect of the ECD using PFM
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One year after Preser Flow Micro Shunt (PFM) surgery, endothelial cell density(ECD) was measured at three locations the central cornea, the cornea proximal to the PFM, and the cornea distal to the PFM on the same day. Factors associated with endothelial cell loss (ECL) were then examined.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 51 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
34 cases that underwent PFM surgery at Fukui Saiseikai Hospital between December 2022 and November 2023.
Key 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nitta |
Organization
Fukui-ken Saiseikai Hospital
Division name
Ophthalmology
Zip code
918-8503
Address
7-1 Wadanakamachi Funabashi, Fukui, Fukui, 918-8503, Japan
TEL
0776231111
nitta.koji7001@fukui.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nitta |
Organization
Fukui-ken Saiseikai Hospital
Division name
Ophthalmology
Zip code
918-8503
Address
7-1 Wadanakamachi Funabashi, Fukui, Fukui, 918-8503, Japan
TEL
0776-23-1111
Homepage URL
nitta.koji7001@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukui-ken Saiseikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui-ken Saiseikai Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui-ken Saiseikai Hospital
Address
7-1 Wadanakamachi Funabashi, Fukui, Fukui, 918-8503, Japan
Tel
0776-23-1111
nitta.koji7001@fukui.saiseikai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The ECD was measured at the central cornea, the cornea near the PFM, and the cornea distal to the PFM. One year after PFM surgery, it was found that in many cases, the endothelial cell count near the PFM had decreased, and the effects gradually extended to the central cornea.
Management information
Registered date
| 2025 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065959
