UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049920 |
|---|---|
| Receipt number | R000056861 |
| Scientific Title | Evaluation of relationship between dry eye and electroencephalography |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/08/08 12:46:18 |
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Basic information
Public title
Evaluation of relationship between dry eye and electroencephalography
Acronym
Relationship between dry eye and electroencephalography
Scientific Title
Evaluation of relationship between dry eye and electroencephalography
Scientific Title:Acronym
Evaluation of relationship between dry eye and electroencephalography
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been pointed out that peripheral and central nerve abnormalities may be involved in the manifestation of symptoms. In particular, in the short BUT type of dry eye, higher brain abnormalities that control the emotional system may be involved in the symptoms. We will conduct research aimed at understanding the activity of electroencephalography (EEG) and examining its relationship with dry eye symptoms.
Basic objectives2
Others
Basic objectives -Others
dry eye parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress level extracted from EEG
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aqueous-deficient dry eye; short BUT dry eye, non-dry eye
Key exclusion criteria
Serious systemic diseases, obvious brain dysfunction, glaucoma patients using eye drops, people wearing contact lenses
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada Eye Clinic
Division name
ophthalmology
Zip code
294-0045
Address
Houjyo 2578-27, Tateyama-shi, Chiba
TEL
0470-22-6311
tomoulton777@ff.em-net.ne.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada Eye Clinic
Division name
ophthalmology
Zip code
2940045
Address
Houjyo 2578-27, Tateyama-shi, Chiba
TEL
0470-22-6311
Homepage URL
tomoulton777@ff.em-net.ne.jp
Sponsor or person
Institute
Wada Ete Clinic
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Itoh Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ito Clinic
Address
Minaminakano626-11, Ohaza, Minuma-ku, Saiatama-shi, Saitama
Tel
048-686-5588
arita.reiko@gmail.com
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
| 2023 | Year | 03 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 15 | Day |
Other
Other related information
observation study
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056861
