UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy and safety of fundus photography and fluorescence fundus photography with smartphone
Title of the study (Brief title)	Smartphone fundus photography and fundus fluorescence photografy
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 and fluorescence fundus photography with smartphone for diagnosis and treatment and education.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The assessment includes the general condition of the patient (ADL, age, underlying disease), environment , possibility of record,image quality ,and whether other doctors can diagnose with the images. Safety is assessed by checking whether there is any ocular damages especially in cornea and retina. Corneal damage is assessed with diagnostic criteria of dry eye( 9-point scale). Retinal damage is assessed by checking the presence of yellow spots of the fovea and other abnormalities by funduscopy. If there are some abnormalities electroretinogram and visual field test.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	We will assess more then 100 cases during 2 years. Fluorescence fundus photography will be applied to patients who need the examination .The examination period ,total number and frequency will be decided depending on the patient's conditions.
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	Subjects for fundus examination with smartphone are the patients we cannot record the funds image with normal cameras in out patient clinic. Main target diseases are retinopathy of prematurity, retinal detachment, retinal hemorrhage , retinal degenerative diseases, macular edema,and optic disc edema. Subjects for fluorescein fundus photography with smartphone are the patients who need normal fluorescein fundus photography and agree with additional examination with smartphone.MAin target diseases are retinal hemorrhage, diabetic retinopathy, retinal vascular occlusion, retinal degenerative diseases, and macular edema.
Key exclusion criteria	Nothing in particular.
Target sample size	100

Research contact person
Name of lead principal investigator	Tetsuro Oshika
Organization	University of Tsukuba
Division name	Department of Ophthalmology
Address	2-1-1 Amakubo, Tsukuba-shi, Ibarakiken 305-8576, Japan
TEL	029-853-3148
Email	sorehasorekorehakore@gmail.com

Public contact
Name of contact person	Shin Suto
Organization	University of Tsukuba
Division name	Department of Ophthalmology
Address	2-1-1 Amakubo, Tsukuba-shi, Ibarakiken 305-8576, Japan
TEL	08041860709
Homepage URL
Email	sorehasorekorehakore@gmail.com

Sponsor
Institute	Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
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	2012 Year 12 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 12 Day
Anticipated trial start date	2013 Year 01 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	2012 Year 12 Month 28 Day
Last modified on	2016 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011338