UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020511 |
|---|---|
| Receipt number | R000023416 |
| Scientific Title | Analysis of the high-order aberrations and tear film lipid layer thickness in the eye of epiphora patients |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2018/04/11 09:32:38 |
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Basic information
Public title
Analysis of the high-order aberrations and tear film lipid layer thickness in the eye of epiphora patients
Acronym
Analysis of the high-order aberrations and tear film lipid layer thickness
Scientific Title
Analysis of the high-order aberrations and tear film lipid layer thickness in the eye of epiphora patients
Scientific Title:Acronym
Analysis of the high-order aberrations and tear film lipid layer thickness
Region
| Japan |
Condition
Condition
Epiphora
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the high-order aberrations and tear film lipid layer thickness in the eye of epiphora patients
Basic objectives2
Others
Basic objectives -Others
comparison between pre and post-operative measure of the high-order aberrations and tear film lipid layer thickness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the high-order aberrations and tear film lipid layer thickness
Key secondary outcomes
pre and post-operative measure of the high-order aberrations and tear film lipid layer thickness
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.the patient who was diagnosed to have lacrimal disorder
2.the patient who were diagnosed not to have lacrimal disorder
3.the patient whose age is 20 years old or older at the time of enrollment
Key exclusion criteria
1.the minor or patient who disagree to participate in this study
2.the patient whose corrected visual acuity is less than 0.4
3.the eye with narrow angle
4.the patient who have apparent kerato-conjunctival disease
5.the patient who have eyelid disease such as entropion and ectropion
6.the patient who have trichiasis
7.the patient who was determined to be difficult of undergoing examinations in this study
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic
Division name
department of ophthalmology
Zip code
Address
6-13 Tawaramachi, Sasebo, Nagasaki 857-0016, Japan
TEL
0956-22-5681
t-mizo@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Fujimoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Schiences
Zip code
Address
54 S hogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3111
Homepage URL
m2fjmt@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Mizoguchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Mizoguchi Eye Clinic
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
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
溝口眼科(長崎県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 20 | 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
| 2016 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case-control study
Rectuiting method of the responders:
all patients which visit mizoguchi eye clinic from February 2016 to January 2017 and match the selection criteria
Measurement item:
The following noninvasive examinations are underwent.
1. functional visual acuity testing
2. wavefront analysis of higher-order aberrations
3. measurement of tear meniscus height
4. measurement of tear film lipid layer depth
5. measurement of meibomian gland morphology
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023416
| Research Plan | |
|---|---|
| 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 |
