UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061563 |
|---|---|
| Receipt number | R000070441 |
| Scientific Title | A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 09:50:47 |
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Basic information
Public title
A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness
Acronym
A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness
Scientific Title
A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness
Scientific Title:Acronym
A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure corneal stiffness (Brillouin values) in normal eyes and keratoconic eyes, categorized by age, disease stage, and pre- vs. post-corneal cross-linking status.
Basic objectives2
Others
Basic objectives -Others
Compare the measured stiffness with various clinical parameters, including visual acuity, intraocular pressure (IOP), corneal refractive power, topography, and corneal thickness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal stiffness (Brillouin longitudinal modulus)
Key secondary outcomes
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who visited the Keratoconus Clinic in the Department of Ophthalmology at Keio University Hospital.
2) Individuals who provide written informed consent to participate in this study.
3) Age: 8 years or older (no upper age limit).
Key exclusion criteria
1) Ocular diseases potentially affecting corneal stiffness (e.g., severe dry eye, corneal scarring, inflammatory corneal disease, bullous keratopathy).
2) History of corneal surgery other than corneal cross-linking.
3) Patients with photosensitivity.
4) Pediatric subjects unable to read or understand the assent form.
5) Individuals deemed unsuitable for participation by the Principal Investigator or Sub-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
naokato@bc.iij4u.or.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 14 | 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
| 2025 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of Corneal Stiffness Using the Brillouin Optical Scanner System (BOSS)
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070441
