UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011123 |
|---|---|
| Receipt number | R000013032 |
| Scientific Title | Histopathological analyses of the membrane tissues on the optic disc in patients with optic disc pit-maculopathy (ODP-M). |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2018/05/13 16:44:41 |
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Basic information
Public title
Histopathological analyses of the membrane tissues on the optic disc in patients with optic disc pit-maculopathy (ODP-M).
Acronym
Histopathological analyses of the membrane tissues on the optic disc in ODP-M.
Scientific Title
Histopathological analyses of the membrane tissues on the optic disc in patients with optic disc pit-maculopathy (ODP-M).
Scientific Title:Acronym
Histopathological analyses of the membrane tissues on the optic disc in ODP-M.
Region
| Japan |
Condition
Condition
optic disc pit-maculopathy
morning glory syndrome
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine histopathologically whether retinal pigment epithelial cells are present in the membrane tissues on the optic disc to investigate the mechanism causing retinal schisis/detachment associated with ODP-M and associated diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of retinal pigment epithelial cells in the membrane tissues on the optic disc
Key secondary outcomes
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
(1) Patients over 20 years of the ages when agreements were taken.
(2) Patients with retinal schisis associated with ODP-M or associated diseases who received the removal of the membrane tissues on the optic disc pit.
(3) Patients that could get agreements by free will of patients themselves following enough understanding after having received enough explanation on participating of this study
Key exclusion criteria
(1) Patients with difficulty regarding making of these specimens because the membrane tissues removed by operation were too small.
(2) In addition, patients whom principal investigator judged to be inappropriate as subjects
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Saito |
Organization
Hokkaido University
Division name
opthalmology
Zip code
Address
Nishi5-chome,Kita14-jou,Kitaku,Sapporoshi,Hokkaido
TEL
011-716-1161
watasai716@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Hokkaido university
Division name
opthalmology
Zip code
Address
Nishi5-chome,Kita14-jou,Kitaku,Sapporoshi,Hokkaido
TEL
08050804592
Homepage URL
atanaka55@gmail.com
Sponsor or person
Institute
Hokkaido university opthalmology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university opthalmology
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
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
| 2013 | Year | 07 | Month | 05 | 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
Immunoreactivity for S100 protein and glial fibrillary acidic protein, markers of astrocytes, was positive in the resected membrane tissues
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
| 2013 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Journal of Ophthalmology, vol. 2018, Article ID 5680503, 12 pages, 2018.
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013032
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