UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009663 |
|---|---|
| Receipt number | R000011338 |
| Scientific Title | Study of the efficacy and safety of fundus photography and fluorescence fundus photography with smartphone |
| Date of disclosure of the study information | 2012/12/29 |
| Last modified on | 2016/12/31 20:25:19 |
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Basic information
Public title
Study of the efficacy and safety of fundus photography and fluorescence fundus photography with smartphone
Acronym
Smartphone fundus photography and fundus fluorescence photografy
Scientific Title
Study of the efficacy and safety of fundus photography and fluorescence fundus photography with smartphone
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tetsuro Oshika |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
Address
2-1-1 Amakubo, Tsukuba-shi, Ibarakiken 305-8576, Japan
TEL
029-853-3148
sorehasorekorehakore@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Suto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
Address
2-1-1 Amakubo, Tsukuba-shi, Ibarakiken 305-8576, Japan
TEL
08041860709
Homepage URL
sorehasorekorehakore@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
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)
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
| 2012 | Year | 12 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011338
