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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020511
Receipt No. 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

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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
Email 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
Email m2fjmt@kuhp.kyoto-u.ac.jp

Sponsor
Institute Mizoguchi Eye Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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