UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035714 |
|---|---|
| Receipt number | R000040678 |
| Scientific 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 |
| Date of disclosure of the study information | 2019/01/30 |
| Last modified on | 2019/01/30 13:36:46 |
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Basic information
Public 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
Acronym
Evaluation of usefulness of ophthalmology specialist diagnosis and AI diagnosis of fundus image and OCT under non-mydriasis utilizing the cloud in internal medicine
Scientific 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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Jun Takeuchi |
Organization
Sapporo diabetes and thyroid clinic
Division name
Diabetes Medicine department
Zip code
Address
Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117071024
jun_takeuchi@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Takeuchi |
Organization
Sapporo diabetes and thyroid clinic
Division name
Diabetes Medicine department
Zip code
Address
Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117071024
Homepage URL
jun_takeuchi@me.com
Sponsor or person
Institute
Sapporo diabetes and thyroid clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040678
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
