UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035155 |
|---|---|
| Receipt number | R000040067 |
| Scientific Title | Questionnaire survey for understanding actual situation in glaucoma patients |
| Date of disclosure of the study information | 2018/12/06 |
| Last modified on | 2024/04/26 13:12:44 |
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Basic information
Public title
Questionnaire survey for understanding actual situation in glaucoma patients
Acronym
Questionnaire survey in glaucoma patients
Scientific Title
Questionnaire survey for understanding actual situation in glaucoma patients
Scientific Title:Acronym
Questionnaire survey in glaucoma patients
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct questioner survey (ex. Evaluation of Flaming effect) for motivating continuous treatment of glaucoma
Basic objectives2
Others
Basic objectives -Others
Questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of selection rate of Therapy A and Therapy B/ Therapy Therapy A and Therapy C and Therapy D between Flaming Question 1 and Flaming Question 2.
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
1.Outpatients in department of Ophthalmology, Jikei University School of Medicine Hospital
2.Male or Female
3.Over the age of 20
4.Diagnosed as Glaucoma
Key exclusion criteria
1.Patient who disagrees on this survey
2.Patient judged as not appropriate to participate this survey by sub-investigator or investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Nakano |
Organization
Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-0003
Address
3-19-18,Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
tnakano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Nakano |
Organization
Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
105-0003
Address
3-19-18,Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
tnakano@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Santen Pharmaceutical Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University School of Medicine
Address
Department of Ophthalmology
Tel
03-3433-1111
rinri@jikei.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
| 2018 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://bmjophth.bmj.com/content/7/1/e000946
Number of participants that the trial has enrolled
147
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
| 2022 | Year | 06 | Month | 24 | 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
| 2018 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey for glaucoma patients
Management information
Registered date
| 2018 | Year | 12 | 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=R000040067
