UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061317 |
|---|---|
| Receipt number | R000070127 |
| Scientific Title | A study on intraocular diffusion following intravenous administration of gadolinium-based contrast agents in patients with glaucoma |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/20 10:52:14 |
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Basic information
Public title
A study on intraocular diffusion following intravenous administration of gadolinium-based contrast agents in patients with glaucoma
Acronym
A study on intraocular diffusion following intravenous administration of gadolinium-based contrast agents in patients with glaucoma
Scientific Title
A study on intraocular diffusion following intravenous administration of gadolinium-based contrast agents in patients with glaucoma
Scientific Title:Acronym
A study on intraocular diffusion following intravenous administration of gadolinium-based contrast agents in patients with glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the relationship between the ocular glymphatic system and glaucoma. By doing so, it may provide new insights into intraocular aqueous humor dynamics and clarify the potential involvement of the glymphatic system in the pathophysiology of glaucoma.
Basic objectives2
Others
Basic objectives -Others
he aim of this study is to evaluate how intravenously administered gadolinium-based contrast agent distributes within the eye and to elucidate the relationship between glaucoma and the glymphatic system. In addition, it aims to identify the ophthalmic factors associated with this process.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast Shift Index of a gadolinium-based contrast agent
Key secondary outcomes
Factors determining the contrast shift index
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma patient
Key exclusion criteria
Patients with hypersensitivity or allergy to gadolinium-based contrast agents
Patients with severe renal impairment or those on dialysis
Pregnant patients
Breastfeeding patients
Patients with asthma
Patients who are unable to undergo MRI examination
Patients with claustrophobia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Yuki |
Organization
Naogya University Graduate School of Meidcine
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65,Tsurumai,Syowa,Naogya-city,Aichi,Japan
TEL
052-741-2111
yuki.kenya.z9@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Yuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65,Tsurumai,Syowa,Naogya-city,Aichi,Japan
TEL
052-741-2111
Homepage URL
yuki.kenya.z9@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Kenya Yuki
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Nagoya University Graduate School of Medicine
Address
65,Tsurumai,Syowa,Naogya-city,Aichi,Japan
Tel
0527412111
ethics@med.nagoya-u.ac.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
| 2026 | Year | 06 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, following a standard intracranial MRI protocol, an additional intracranial MRI scan without contrast is performed 4 hours later, and the data are collected. Ophthalmic data are extracted from the electronic medical records. A paper-based case report form is used for data collection.
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070127
