UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047456 |
|---|---|
| Receipt number | R000054115 |
| Scientific Title | Remote visual ADL investigation for retinitis pigmentosa |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/09/12 15:01:26 |
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Basic information
Public title
Remote visual ADL investigation for retinitis pigmentosa
Acronym
Re-RP LVFAM prototype
Scientific Title
Remote visual ADL investigation for retinitis pigmentosa
Scientific Title:Acronym
Re-RP LVFAM prototype
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tolerability study of the new LVFAM, a modified version of the Visual ADL Questionnaire (LVFAM) for retinitis pigmentosa (RP) and remote use.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tolerability Checklist
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Retinitis pigmentosa patients in the outpatient clinic of Chiba University Department of Ophthalmology
2) Visited between January 1, 2022 and September 30, 2022
3) History of Humphrey Field of View (HFA) 10-2 measurements
4) Corrected visual acuity in both eyes in the range of 0.2 to 0.9
Key exclusion criteria
(1) 20 years of age or older and less than 80 years of age
(3) Patients with other ophthalmologic diseases that affect visual function
4) Cases of blindness in one eye
(5) Cases with significant fluctuations in visual function and findings
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Sugawara |
Organization
Chiba University Hpspital
Division name
Ophthalmology
Zip code
260-8677
Address
Chiba City, Chuo-ku, Inohana 1-8-1
TEL
0432227171
takeshis@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Sugawara |
Organization
Chiba University Hospital
Division name
Ophthalmology
Zip code
260-8677
Address
Chiba City, Chuo-ku, Inohana 1-8-1
TEL
0432227171
Homepage URL
takeshis@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
Chiba University Hospital
Address
Chiba City, Chuo-ku, Inohana 1-8-1
Tel
0432227171
takeshis@faculty.chiba-u.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
| 2022 | Year | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 12 | Day |
Other
Other related information
questionnaire survey
Management information
Registered date
| 2022 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
