UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024517 |
|---|---|
| Receipt number | R000028219 |
| Scientific Title | Ocular manifestations of Congenital insensitivity to pain with anhidrosis in Japan |
| Date of disclosure of the study information | 2016/10/22 |
| Last modified on | 2022/10/25 16:47:40 |
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Basic information
Public title
Ocular manifestations of Congenital insensitivity to pain with anhidrosis in Japan
Acronym
Ocular manifestations of CIPA in Japan
Scientific Title
Ocular manifestations of Congenital insensitivity to pain with anhidrosis in Japan
Scientific Title:Acronym
Ocular manifestations of CIPA in Japan
Region
| Japan |
Condition
Condition
Congenital insensitivity to pain with anhidrosis; CIPA (Hereditary sensory and autonomic neuropathy types IV)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe ocular manifestations in Japanese patients with hereditary sensory and autonomic neuropathy (HSAN) types IV and V, focusing particularly on the status of the ocular surface, meibomian glands and pupil.
Basic objectives2
Others
Basic objectives -Others
To describe ocular manifestations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluorescein staining scores of cornea and conjunctiva, lipid layer thickness, diameter and shape of pupil
Key secondary outcomes
Visual acuity, ocular alignment, binocular vision, external ocular movement, lid margine abnormalities, tear interferometric pattern, tear meniscus, non-invasive tear break-up time, tear break-up time with fluorescein, Meiboscore, meibum score, corneal opacity
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Congenital insensitivity to Pain with Anhidrosis
Key exclusion criteria
non-cooperation of examinations
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Miyai |
Organization
The University of Tokyo Hosopital
Division name
Ophthalmology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
miyataka381@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Miyai |
Organization
The University of Tokyo Hosopital
Division name
Ophthalmology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
+81-3-3815-5411
Homepage URL
miyataka381@gmail.com
Sponsor or person
Institute
The University of Tokyo Hosopital
Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hosopital
Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
Tel
+81-3-5841-3600
ethics@m.u-tokyo.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
| 2016 | Year | 10 | Month | 22 | 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
| 2016 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study. Case control study.
Management information
Registered date
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028219
