UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018508 |
|---|---|
| Receipt number | R000021423 |
| Scientific Title | Survey of Meibomian gland dysfunction |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2017/07/24 11:02:30 |
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Basic information
Public title
Survey of Meibomian gland dysfunction
Acronym
Survey of Meibomian gland dysfunction
Scientific Title
Survey of Meibomian gland dysfunction
Scientific Title:Acronym
Survey of Meibomian gland dysfunction
Region
| Japan |
Condition
Condition
Meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the prevalence of MGD in Japanese and compare it with that in other races.
2. To evaluate the efficacy of diagnostic criteria of MGD working group in Japan.
3. To establish questionnaire for diagnosis of MGD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Symptoms
2. Slit lamp
3. Tear film breakup time
4. Meibography
5. Tear volume , Tear thickness
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
20 years old or older
Male and female
Key exclusion criteria
Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to initiation of the clinical research.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Amano |
Organization
Inouye Eye Hospital
Division name
Ophthalmology
Zip code
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
amanoshiro1126@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Amano |
Organization
Inouye Eye Hospital
Division name
Ophthalmology
Zip code
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
Homepage URL
amanoshiro1126@gmail.com
Sponsor or person
Institute
Inouye Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団 済安堂 お茶の水・井上眼科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects are consecutive patients who are scheduled to undergo cataract surgery at Inouye eye hospital. Subjects undergo questionnaire for dry eye and MGD, slit-lamp examination, tear breakup time, meibography, and Schirmer test.
In a population-based study, the prevalence of MGD was 31%.
Management information
Registered date
| 2015 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021423
