UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of usefulness of ophthalmology specialist diagnosis and AI diagnosis of fundus image and OCT under non-mydriasis utilizing the cloud in internal medicine
Title of the study (Brief title)	Evaluation of usefulness of ophthalmology specialist diagnosis and AI diagnosis of fundus image and OCT under non-mydriasis utilizing the cloud in internal medicine
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	About patients with diabetes during our hospital visit (A)Patients who follow follow only in the hospital fundus examination (B) Patients who underwent in-hospital fundus examination and underwent routine ophthalmic examination (C) Patients who underwent in-hospital fundus examination and ophthalmologic examination together Cross-sectional and continuous investigation Identify the usefulness of this system Identify problems of this system To clarify the borderline of the patient background (blood sugar control, morbidity period, extent of complications, etc.) for safely operating this system Development of an AI system to assist diagnosis of physicians on the day (to estimate lesions imagewise from fundus images and OCT) Investigate the relationship between OCT digitized data and glycemic control and identify later predictors of development of diabetic retinopathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of diagnosis of diabetic retinopathy with mydriatic fundus examination performed in internal medicine and mydriasis fundus examination performed in ophthalmology
Key secondary outcomes	1) Comparison of results of fundus examination and glycemic control in internal medicine 2) Comparison of results of fundus examination and diabetic complications in internal medicine 3) Comparison of results of fundus examination in internal medicine with patient background 4) Incidence rate of OCT digitized data and blood glucose control and subsequent retinopathy 5) Estimation of lesions by healthy and pathologic fundus image and OCT image pattern and comparison of interpretation results by ophthalmologist using cloud 6) Changes in ocular examination rates after examination of the fundus in internal medicine and patient guidance using it 7) Comparison of the time of diagnosis of diabetic retinopathy with follow-up observation by non-mydriatic fundus examination in the internal medicine and ophthalmology and the visual function and prognosis associated with the rate of progression of retinopathy and retinopathy

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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients in our hospital visit at the diagnosis of diabetes mellitus Patients who refuse to participate in this study
Key exclusion criteria	Patients who refuse to participate in this study Patient who can not clearly visualize both sides of the fundus due to monocular or cataract
Target sample size	1000

Research contact person
Name of lead principal investigator	Jun Takeuchi
Organization	Sapporo diabetes and thyroid clinic
Division name	Diabetes Medicine department
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	0117071024
Email	jun_takeuchi@me.com

Public contact
Name of contact person	Jun Takeuchi
Organization	Sapporo diabetes and thyroid clinic
Division name	Diabetes Medicine department
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	0117071024
Homepage URL
Email	jun_takeuchi@me.com

Sponsor
Institute	Sapporo diabetes and thyroid clinic
Institute
Department

Funding Source
Organization	Sapporo diabetes and thyroid clinic
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	2019 Year 01 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 30 Day
Anticipated trial start date	2019 Year 01 Month 30 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	1) Background information (at time of case registration): age, sex, medical history, diagnosis name, history of complications, lifestyle disease disease and ophthalmology treatment history 2) Inferior mydriasis examination of fundus oculi: left and right fundus images (3Dwide), left and right OCT (Radial, 3DWide) 3) Ophthalmic visit: visual acuity, intraocular pressure, eye fundus image inspection result under mydriasis 4) Blood test (at least once a year): glucose tolerance test, lipid metabolism, liver function, kidney function, electrolyte 5) Urinalysis (once a year or more): general urinalysis, albumin, protein, creatinine 6) Physiological examination (once a year): electrocardiogram, ABI / PWV, carotid echo 7) Foot check (once a year): confirmation of diabetic foot lesion

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2019 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040678