UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023432 |
|---|---|
| Receipt number | R000026996 |
| Scientific Title | Morphological evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease |
| Date of disclosure of the study information | 2016/08/02 |
| Last modified on | 2021/02/15 10:00:25 |
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Basic information
Public title
Morphological evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease
Acronym
Confocal microscopic findings for dry eye disease
Scientific Title
Morphological evaluation using in vivo confocal microscopy on ocular surface in patients with dry eye disease
Scientific Title:Acronym
Confocal microscopic findings for dry eye disease
Region
| Japan |
Condition
Condition
Dry eye disease
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate ocular surface condition by in vivo confocal microscopy.
Basic objectives2
Others
Basic objectives -Others
Evaluatio of ocular surface and tear dynamics for dry eye disease group and control group.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of dry eye disease
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. Diagnostic criteria by Japanese Dry Eye Society 2006
Definite dry eye disease
2. Adult over 20 years old
Written informed consent
3. Meibomian gland dysfunction
Key exclusion criteria
1. No dry eye disease
2. No written informed consent
3. No meibomian gland dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
Department of Ophthalmology, Keio University School of Medicine 35 Shinanomachi Shinjuku-ku Tokyo, 160-8582, Japan
TEL
0353633972
ophthalmolog1st.acek39@keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
Department of Ophthalmology, Keio University School of Medicine 35 Shinanomachi Shinjuku-ku Tokyo, 1
TEL
0353633972
Homepage URL
yoko@z7.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
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
| 2016 | Year | 08 | Month | 02 | 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
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
| 2013 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | 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=R000026996
