UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020963 |
|---|---|
| Receipt number | R000024188 |
| Scientific Title | observation of natural history in retinitis pigmentosa |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2022/02/16 10:18:38 |
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Basic information
Public title
observation of natural history in retinitis pigmentosa
Acronym
observation of natural history in retinitis pigmentosa
Scientific Title
observation of natural history in retinitis pigmentosa
Scientific Title:Acronym
observation of natural history in retinitis pigmentosa
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to observe natural history of retinitis pigmentosa precisely
Basic objectives2
Others
Basic objectives -Others
observation of natural history
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
progression in visual field defect
Key secondary outcomes
retinal thickness in OCT observation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as retinitis pigmentosa who agreed to be included in this study
Key exclusion criteria
history of ocular surgeries other than cataract surgery,history of other eye diseases
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hanako O Ikeda |
Organization
Kyoto university
Division name
ophthalmology
Zip code
Address
54, Shogoin-Kawaharacho, Kyoto
TEL
0757513727
rpkyoto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Hasegawa |
Organization
Kyoto university
Division name
ophthalmology
Zip code
Address
54, Shogoin-Kawaharacho, Kyoto
TEL
0757513727
Homepage URL
rpkyoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university, departmentof ophthalomogy
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation of natural history of visual field progression
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024188
