UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053808 |
|---|---|
| Receipt number | R000061415 |
| Scientific Title | Autonomic nerve activity under several eye conditions in short BUT dry eye |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/08 17:25:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Autonomic nerve activity under several eye conditions in short BUT dry eye
Acronym
ANA under several eye conditions in short BUT DE
Scientific Title
Autonomic nerve activity under several eye conditions in short BUT dry eye
Scientific Title:Acronym
ANA under several eye conditions in short BUT DE
Region
| Japan |
Condition
Condition
Short BUT dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure autonomic nerve activity (ANA) in several eye conditions and verify whether the modulation of ANA is regulated by peripheral or central control in short break up time of tear film (BUT) DE (sBUTDE).
Basic objectives2
Others
Basic objectives -Others
To investigate the factors associated with the symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ANA under closed eyes, opened eyes, opened eyes with ocular surface anesthesia
Low frequency (LF), High frequency (HF), Ratio of LF to HF (LF/HF), Coefficient of Component Variance LF (ccvLF),Coefficient of Component Variance HF (ccvHF)
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
Short BUT dry eye
the presence of DE symptoms, BUT 5 seconds or less, vital staining score less than 3 points
Key exclusion criteria
cular surgery and trauma within the last 12 months, permanent structural damage due to ocular trauma, receiving pressure-lowering agents for the treatment of glaucoma, current contact lens use, and systemic diseases including metabolic, cardiovascular, and pulmonary diseases
Target sample size
50
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
2940045
Address
Houjyo 2578-27, Tateyama-shi, Chiba
TEL
08020409157
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
1040061
Address
Houjyo 2578-27, Tateyama-shi, Chiba
TEL
08020409157
Homepage URL
tomoulton777@ff.em-net.ne.jp
Sponsor or person
Institute
Wada Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
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
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ANA did not change by ocular surface anesthesia in both sBUTDE and control groups. In sBUTDE, HF and ccvHF were higher, and LF over HF was lower when the eyes were open than when the eyes were closed, whereas non-DEs showed the opposite responses. The personality test showed the tendency to be less openness and higher neuroticism in the sBUTDE group. Factors associated with the presence or absence of DE symptoms were BUT , HF under open eyes, and feeling of openness.
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061415
