UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the high-order aberrations and tear film lipid layer thickness in the eye of epiphora patients
Title of the study (Brief title)	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	Takanori Mizoguchi
Organization	Mizoguchi Eye Clinic
Division name	department of ophthalmology
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	Masahiro Fujimoto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Schiences
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023416