UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Photography of ophthalmic observations with Smartphone
Title of the study (Brief title)	Photography of ophthalmic observations with Smartphone
Region	Japan

Condition
Condition	All vitreoretinal diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of funduscopy with smartphone.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We assess ocular damages by funduscopy.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients we cannot record the fundus image with normal cameras.
Key exclusion criteria	Nothing
Target sample size	100

Research contact person
Name of lead principal investigator	Motohiro Kamei
Organization	Aichi medical university
Division name	Department of Ophthalmology
Address	1-1 karimata,yazako,Nagakute-shi, Aichiken 480-1195, Japan
TEL	0561-62-3311
Email	kamei.motohiro.169@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	Keijiro Sugita
Organization	Aichi medical university
Division name	Department of Ophthalmology
Address	1-1 karimata,yazako,Nagakute-shi, Aichiken 480-1195, Japan
TEL	0561-62-3311
Homepage URL
Email	sugita.keijirou.734@mail.aichi-med-u.ac.jp

Sponsor
Institute	Department of Ophthalmology,Aichi medical university
Institute
Department

Funding Source
Organization	Aichi medical university
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 24 Day
Anticipated trial start date	2015 Year 08 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	Subjects for fundus photography with smartphone are the patients who cannot sit down and we cannot record the fundus photography with normal camera.

Management information
Registered date	2015 Year 07 Month 24 Day
Last modified on	2017 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020955