UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effectivness of the Eyelid clamper
Title of the study (Brief title)	Evaluation of effectivness of the Eyelid clamper
Region	Japan

Condition
Condition	retinal disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of using Eyelidclamper while aquiring retinal image by the optos
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	area of the retina imaged using Eyelid clamper and optos
Key secondary outcomes	marginal reflex distance while applying the Eyelid clamper corneal change after using Eyelid clamper

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	patients who visit Keio University Hospital ophthalmology department
Key exclusion criteria	corneal disease patient who had eye surgery within 6 months active infectious inflammation
Target sample size	50

Research contact person
Name of lead principal investigator	Toshihide Kurihara
Organization	Keio University
Division name	School of Medicine, Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	kurihara@z8.keio.jp

Public contact
Name of contact person	Nobuhiro Ozawa
Organization	Keio University
Division name	School of Medicine, Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	n.ozw@z5.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	None
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	YES
Study ID_1	20170235
Org. issuing International ID_1	Keio University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 21 Day
Anticipated trial start date	2018 Year 02 Month 07 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	area of retinal image acquired by the Optos

Management information
Registered date	2018 Year 02 Month 04 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035512