UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050635 |
|---|---|
| Receipt number | R000057681 |
| Scientific Title | Remote visual ADL study for retinitis pigmentosa "Real" LVFAM2 |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2024/03/21 07:24:35 |
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Basic information
Public title
Remote visual ADL study for retinitis pigmentosa "Real" LVFAM2
Acronym
RealLVFAM2
Scientific Title
Remote visual ADL study for retinitis pigmentosa "Real" LVFAM2
Scientific Title:Acronym
RealLVFAM2
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Second study to remotely administer the LVFAM visual ADL survey to patients with retinitis pigmentosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tolerance Checklist
Key secondary outcomes
Correlation of LVFAM with macular sensitivity
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) retinitis pigmentosa
Key exclusion criteria
1) other eye diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 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
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
Ministry of Education
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
| 2023 | Year | 05 | Month | 08 | 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
15
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 04 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 04 | Day |
Other
Other related information
Visual ALD Questionnaire Survey
Management information
Registered date
| 2023 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057681
