UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048646 |
|---|---|
| Receipt number | R000051840 |
| Scientific Title | Association between temperature and blood flow in dry eye patients |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2022/08/10 21:02:14 |
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Basic information
Public title
Association between temperature and blood flow in dry eye patients
Acronym
Association between temperature and blood flow in dry eye patients
Scientific Title
Association between temperature and blood flow in dry eye patients
Scientific Title:Acronym
Association between temperature and blood flow in dry eye patients
Region
| Japan |
Condition
Condition
Dry eye patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure ocular surface temperature and ocular blood flow in patients with dry eye, and to clarify the relationship between ocular surface blood flow and temperature according to the clinical findings of dry eye and the severity of subjective symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular surface temperature
Blood flow
Key secondary outcomes
subjective symptom
tear film stability
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Dry eye patients aged 20 years and older
Key exclusion criteria
Patients with allergic conjunctivitis, corneal infection, and within one month after ophthalmic surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hori |
| Middle name | |
| Last name | Yuichi |
Organization
Toho University Omori medical center
Division name
Ophthalmology
Zip code
143-8541
Address
ota ku omori nish 6-11-1
TEL
0337624151
takashi.itokawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Itokawa |
| Middle name | |
| Last name | Takashi |
Organization
Toho university omori medical center
Division name
Ophthalmology
Zip code
143-8541
Address
Ota ku omori nish 6-11-1
TEL
0337624151
Homepage URL
takashi.itokawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical center
Institute
Department
Personal name
Funding Source
Organization
Toho University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho university omori medical center
Address
Ota ku Omori Nish 6-11-1
Tel
0337624151
takashi.itokawa@med.toho-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
| 2022 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051840
