UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045396 |
|---|---|
| Receipt number | R000051800 |
| Scientific Title | Video-recorded study of eyedrops instillation skill and medication guidance in glaucoma patients. |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2024/04/26 13:24:26 |
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Basic information
Public title
Video-recorded study of eyedrops instillation skill and medication guidance in glaucoma patients.
Acronym
Video-recorded study of eyedrops instillation skill and medication guidance in glaucoma patients.
Scientific Title
Video-recorded study of eyedrops instillation skill and medication guidance in glaucoma patients.
Scientific Title:Acronym
Video-recorded study of eyedrops instillation skill and medication guidance in glaucoma patients.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Difference in instillation success rate between self-assessment and objective assessment using recorded video.
Basic objectives2
Others
Basic objectives -Others
Difference of instillation success rate between self-assessment and objective assessment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of instillation success rate between self-assessment and objective assessment using recorded video.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma patients newly referred to the ophthalmology department of Shimane University Hospital
Eye instillation guidance using artificial tears is considered necessary at the discretion of the research director or research subinvestigator of the medical institution.
Visual acuity of better eyes with corrected visual acuity of 0.3 or more and video viewable.
Key exclusion criteria
Those who have hypersensitivity to drugs used in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane university faculty of medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
89-1, Enya, Izumoshi, Shimane
TEL
0853-20-2284
mtanito@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane University faculty of medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
89-1, Enya, Izumoshi, Shimane
TEL
0853-20-2284
Homepage URL
mtanito@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
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
Shimane University Hospital Clinical Trial Center
Address
89-1, Enya, Izumoshi, Shimane, 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2021 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12325-023-02646-3
Number of participants that the trial has enrolled
60
Results
Refer to paper
Results date posted
| 2024 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 14 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
IPD sharing Plan description
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 04 | Month | 04 | Day |
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051800
