UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055801 |
|---|---|
| Receipt number | R000063251 |
| Scientific Title | Data Collection Study on Glaucoma Diagnosis Support Program |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2024/10/10 18:10:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Data Collection Study on Glaucoma Diagnosis Support Program
Acronym
Data Collection Study on Glaucoma Diagnosis Support Program
Scientific Title
Data Collection Study on Glaucoma Diagnosis Support Program
Scientific Title:Acronym
Data Collection Study on Glaucoma Diagnosis Support Program
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Glaucoma is the leading cause of visual impairment in Japan, accounting for just under one-quarter of all cases, and although the prevalence of glaucoma in people over 40 years of age is 5.0%, the number of undetected potential patients is as high as 89.5%. Starting treatment for glaucoma at an early, unrecognized stage has the potential to reduce its progression and preserve vision throughout life, but existing standard diagnostic protocols require patients to visit an urban ophthalmologist in person. This makes fundus examination and glaucoma diagnosis extremely difficult to obtain for patients who are unable to visit an urban ophthalmologist due to economic, geographic, or physical factors. In this study, healthcare professionals will use a smartphone-connected fundus camera to observe the fundus and collect images and clinical information. This will allow us to observe the shape of the fundus depending on the presence or absence of glaucoma, and to collect learning data and validation data (images and clinical information) for the future development of a glaucoma diagnosis support AI program.
Basic objectives2
Others
Basic objectives -Others
N/A (for data collection study)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N/A (for data collection study)
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A smartphone-connected fundus camera is brought to approximately 20 mm in front of the eye to acquire fundus images. In this study, an iPhone 13 will be used as the smartphone.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients who are at least 18 years of age and less than 80 years of age (regardless of gender) at the time consent is obtained
2. patients whose consent to participate in this study is obtained in writing
3. patients who are deemed by the physician to have ocular fundus diseases that are desirable to be examined
4. patients who are capable of mydriasis
Key exclusion criteria
1. Patients with a history of hypersensitivity to the pupil drug (tropicamide phenylephrine hydrochloride ophthalmic solution)
2. patients who have been judged by the principal investigator or a subinvestigator of the study to be unjustly disadvantaged by participation in the study
3. Patients whose participation in the study has been judged by the principal investigator or a subinvestigator to cause difficulty in the conduct or evaluation of this clinical study.
Target sample size
640
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Hirooka |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5246
kazuyk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Tokumo |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5246
Homepage URL
kanatokumo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
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
| 2024 | Year | 10 | Month | 10 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063251
