UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035886 |
|---|---|
| Receipt number | R000040885 |
| Scientific Title | Evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease related to short tear film breakup time |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2021/02/15 10:06:23 |
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Basic information
Public title
Evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease related to short tear film breakup time
Acronym
Confocal microscopic findings for dry eye disease related to short BUT
Scientific Title
Evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease related to short tear film breakup time
Scientific Title:Acronym
Confocal microscopic findings for dry eye disease related to short BUT
Region
| Japan |
Condition
Condition
Dry eye disease related to short tear-film breakup time
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate ocular surface condition in dry eye disease related to short tear-film breakup time by in vivo confocal microscopy.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether the results are useful to determine the prediction of therapeutic intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of ocular surface condition
(Grading of squamous metaplasia, Density of inflammatory cells and goblet cells, Presence or absence of corneal nerve abnormality)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult (Over or equal 20 years old) who can be obtained the written informed consent.
2. Subjects
Dry eye disease related to short tear-film breakup time.(20 cases)
3. Controls
Patients who do not fulfill the criteria for dry eye disease or meibomian gland dysfunction.(20 cases)
*Diagnostic criteria for dry eye disease is based on the revised criteria in 2016 by Japanese dry eye disease society.
Key exclusion criteria
1. Difficulty for examination by HRTII-RCM due to the patient's physical and mental condition.
2. Disadvantage by the examination for the patients.
3. No informed consent
4. No ophthalmic surgeries
5. No contact lens wearer
6. No VDT workers more than or equal 4 hours
7. Patients who are not eligible for entry judged by the principal investigators and collaborators in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
0333531211
ophthalmolog1st.acek39@keio.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Shimizu |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
ophthalmolog1st.acek39@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Keio University School of Medicine
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku
Tel
0333531211
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 18 | 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
| 2019 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Corneal sensitivity
Value of Shirmer test
Fluorescein score
Rose Bengal or Lissamin green score
Symptom questionnaire
Evaluation by In vivo laser confocal micoscopy(Heidelberg Retina Tomograph II-Rostock Cornea Module (HRTII-RCM))
Management information
Registered date
| 2019 | Year | 02 | Month | 15 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040885
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
