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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043926
Receipt No. R000050160
Scientific Title Construction of registry for Bietti's crystalline dystrophy
Date of disclosure of the study information 2021/05/10
Last modified on 2021/10/20

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Basic information
Public title Natural history of Bietti's crystalline dystrophy
Acronym Natural history of Bietti's crystalline dystrophy
Scientific Title Construction of registry for Bietti's crystalline dystrophy
Scientific Title:Acronym Construction of registry for Bietti's crystalline dystrophy
Region
Japan

Condition
Condition Bietti's crystalline dystrophy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the natural history of crystallin retinopathy for the development of new treatments for crystallin retinopathy
Basic objectives2 Others
Basic objectives -Others Natural course at the time of clinical trials scheduled to be conducted in the future, purpose of recruitment
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of visual acuity
Key secondary outcomes MD vale of Hanphery Visual Field test

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 Patients clinically diagnosed with crystallin retinopathy
Key exclusion criteria Retinas other than crystallin retinopathy, cases with optic nerve disease, minors and elderly patients with concerns about judgment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hanako
Middle name Ohashi
Last name Tsujikawa
Organization Kyoto University
Division name Ophthalmology
Zip code 6068507
Address 54
TEL 0757513248
Email rpkyoto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hanako
Middle name Ohashi
Last name Ikeda
Organization Kyoto University
Division name Ophthalmology
Zip code 6068507
Address 54
TEL 0757513248
Homepage URL
Email rpkyoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization AMED
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 Kyoto University Graduate School of Medicine / Faculty of Medicine and Hospital Medical Ethics Committee
Address 54
Tel 0757513248
Email ethcom@kuhp.kyoto-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 05 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 Open public recruiting
Date of protocol fixation
2021 Year 04 Month 13 Day
Date of IRB
2020 Year 04 Month 08 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 04 Month 14 Day
Last modified on
2021 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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