UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049234 |
|---|---|
| Receipt number | R000056070 |
| Scientific Title | Development of a general-purpose smartphone opthalmoscope |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2024/10/18 16:48:51 |
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Basic information
Public title
Development of a general-purpose smartphone opthalmoscope
Acronym
Development of a general-purpose smartphone opthalmoscope
Scientific Title
Development of a general-purpose smartphone opthalmoscope
Scientific Title:Acronym
Development of a general-purpose smartphone opthalmoscope
Region
| Japan |
Condition
Condition
normal retina, papillary edema, branch retinal vein occlusion
Classification by specialty
| Pediatrics | Ophthalmology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, a smartphone opthalmoscope (SO) has been developed as a fundoscope that can be used by non-ophthalmologists. For non-ophthalmologists, SO has been shown to be easier to use than conventional indirect opthalmoscopes and to evaluate the retina more quickly and more accurately. Furthermore, the SO allows retinal findings to be stored as images. On the other hand, the potential use of SO in children, who have smaller pupil diameters than adults, has not been fully evaluated. In general, the smaller the pupil diameter, the greater the likelihood that the misalignment between the optical and visual axes of the smartphone video will make retinal viewing difficult. Hence, there is a need to minimize the misalignment of the optical and visual axes, increase the refractive index of the lens used, and improve fixation of the device. Another problem is that SOs currently available on the market are limited to specific smartphones.
In this study, we have developed an SO to accommodate pupil diameters smaller than those of adults. To validate the feasibility of using this SO in medical practice, we plan to conduct a study to evaluate retinal images in an ocular model, retinas in healthy volunteers, and retinas in critically ill patients in a step-by-step manner. In the present study, we examine a hypothesis that this SO will allow non-ophthalmologists to obtain videos from adult and pediatric eye models that can withstand ophthalmologist diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For each of the adult and pediatric eye models, two ophthalmologists independently evaluated whether the stored videos by study participants were of diagnostic value or not.
Key secondary outcomes
(A) For each of the adult and pediatric eye models, two ophthalmologists independently evaluate the stored video quality (i) and (ii).
(i) Overall image quality (3-point scale: excellent, fair, and poor)
Excellent: the entire posterior pole is in focus. The posterior pole includes the retina between the optic nerve papilla and the arcade vessels, the macula and the optic nerve papilla.
Acceptable: too bright, too dark, or out of focus but sufficient to determine the presence or absence of a lesion
Impossible: out of focus or obscured by reflections or artifacts.
(ii) Accuracy of depiction of each anatomic merkmal (optic nerve papilla, macula, upper arcade vessels, lower arcade vessels) (3-point scale: not visible, visible but image quality is poor, visible and image quality is adequate)
(iii) Percentage of correct diagnosis by the study participants
(iv) Inter-rater agreement rate between the two opthalmologists
(B) Comparison between adult and pediatric eye models for all the above items
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 following medical students and physicians whose consent was obtained during the period:
Medical students and junior residents training in pediatrics
Senior residents training in pediatrics, pediatricians, emergency and intensive care physicians
All affiliated with the University of Tokyo Faculty of Medicine or the University of Tokyo Hospitals.
Key exclusion criteria
The medical students or physicians who do not consent
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Hayashi |
Organization
The University of Tokyo Hospital
Division name
The Department of Pediatrics
Zip code
113-8655
Address
7 Chome-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3815-5411
hayashik-ped@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Hayashi |
Organization
The University of Tokyo Hospital
Division name
The Department of Pediatrics
Zip code
113-8655
Address
7 Chome-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-4815-5411
Homepage URL
hayashik-ped@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
NIPRO
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7 Chome-3-1 Hongo, Bunkyo City, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022171NI
Org. issuing International ID_1
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
*One person was excluded from the analysis due to incomplete data acquisition.
Results
percentage of retinal videos suitable for diagnosis: Adult model 96/99, Pediatric model 98/99
Median video recording time (quartile): Adult model 30 seconds (21-48.5 seconds), Pediatric model 18 seconds (14-31.0 seconds)
Gwet's AC1: Adult model 0.98, Pediatric model 0.99
Results date posted
| 2024 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant Background
Total: 99
Medical students: 36
Junior residents: 5
Pediatricians: 35
Emergency physicians: 23
Participant flow
Adverse events
No advers events were reported.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an exploratory cross-sectional study and no observations will be made after the study date for each study paticipant.
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056070
