UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical utility of next generation optical coherence tomography for accessory visual structurescoherence tomography
Title of the study (Brief title)	The clinical utility of OCT for accessory visual structures
Region	Japan

Condition
Condition	accessory visual structures
Classification by specialty	Ophthalmology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluating clinical utility of next generation optical coherence tomography for accessory visual structures
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison between normal and disease states in lacrimal apparatus using OCT image
Key secondary outcomes	Comparison between benign and malignant eyelid tumor using OCT image

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Evaluating accessory visual structures in disease states using next generation optical coherence tomography Intervention frequency is 3 times; initial visit, postoperative monnths 2,6.
Interventions/Control_2	Evaluating accessory visual structures in normal states using next generation optical coherence tomography Intervention frequency is one time.
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.patients who were diagnosed as lacrimal disease or eyelid tumor in Kyoto university 2.patients who are normal states in accessory visual structures
Key exclusion criteria	1.patients who had allergy caused by rebamipido eye-drop 2.patients who didn't agree with this study 3.patients who were judged to be unsuitable to this study by us
Target sample size	130

Research contact person
Name of lead principal investigator	Nagahisa Yoshihisa
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shogoin-Kawaracho, Sakyou, Kyoto 606-8507
TEL	075-751-3250
Email	nagaeye@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Masahiro Fujimoto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shogoin-Kawaracho, Sakyou, Kyoto 606-8507
TEL	075-751-3250
Homepage URL
Email	m2fjmt@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	japan society for promotion of science
Organization
Division
Category of Funding Organization	Other
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	京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 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

Management information
Registered date	2015 Year 10 Month 09 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=R000022199