UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054622 |
|---|---|
| Receipt number | R000062414 |
| Scientific Title | Dynamic layer-by-layer assessment of the tear film |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/10/25 19:21:05 |
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Basic information
Public title
Dynamic layer-by-layer assessment of the tear film
Acronym
TF imaging
Scientific Title
Dynamic layer-by-layer assessment of the tear film
Scientific Title:Acronym
TF imaging
Region
| Japan |
Condition
Condition
Dry eye, dry eye suspect, and eyes with abrnomal tear film/ocular surface
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate tear dynamics in dry eyes and eyes with abnormal tear film using a device that can simultaneously observe the thickness of the aqueous and lipid layers of the tear fim noninvasively
Basic objectives2
Others
Basic objectives -Others
This study is not intended to confirm the efficacy or safety of the devices. The purpose is to conduct research to further pursue the relationship between the optical properties of tear fluid and visual function by performing a comprehensive evaluation including temporal changes in the tear film, which at this stage can only be done using separate devices, similar to conventional commercial devices.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal changes in lipid layer and aqueous layer thickness, dynamic mapping of the lipid layer
Key secondary outcomes
Tear breakup time and sybjective symptoms, based on diagnostic criteria of dry eye (Asia Dry Eye Society)
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
Patients with dry eye or suspected dry eye based on the 2016 dry eye diagnostic criteria, Patients with abrnomal tear film/ocular surface requiring differential diagnosis including dry eye, Patients who are 20 years of age or older at the time of obtaining consent and who have given written consent to participate in the research
Key exclusion criteria
Patients who do not wish to be examined, Patients with poor vision and difficulty with fixation, Patients for whom the test is not reliable, Other patients deemed inappropriate by the Principal Investigator/Investigator.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
5650871
Address
Rm. E7, 2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3456
knishida@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizuka |
| Middle name | |
| Last name | Koh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
650-0044
Address
Rm. E7, 2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3456
Homepage URL
cizciz@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Shizuka Koh
Funding Source
Organization
Topcon
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
+81-6-6210-8296
rinri@hp-crc.med.osaka-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
| 2024 | Year | 07 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Normal healthy conrols are not included. Performed during a regular outpatient visit. No prior screening and no treatment intervention. Although the device used is a prototype, safety standards are equivalent to those of commercially available medical devices. The thickness of the liquid and oil layers of the lacrimal fluid layer can be measured simultaneously in a noninvasive, non-contact, quantitative manner. This study does not confirm the efficacy or safety of the device. This study is similar to a routine outpatient examination, and there are no medical procedures that will burden the patient other than time. Diagnosis, treatment, and other medical policies will not be affected by this evaluation.
Management information
Registered date
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062414
