UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031223 |
|---|---|
| Receipt number | R000035455 |
| Scientific Title | Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia. |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2020/02/12 09:28:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Acronym
Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Scientific Title
Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Scientific Title:Acronym
Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Region
| Japan |
Condition
Condition
high myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between posterior staphyloma and high myopia
Basic objectives2
Others
Basic objectives -Others
risk factor of posterior staphyloma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measure the refraction value, visual acuity, axial length and so on every six months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Retrospective study: patients who have already developped posterior staphyloma
Prospective study: patients aged between 40 and 50 who have not developped posterior staphyloma in both eyes or have developped posterior staphylpma in one eye
Key exclusion criteria
other than those above
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-8566
Address
465 Kajii-cho,Kamigyo-ku,Kyoto city
TEL
075-251-5578
msasaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Sasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-8566
Address
465 Kajii-cho,Kamigyo-ku,Kyoto city
TEL
075-251-5578
Homepage URL
msasaki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
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 Prefectural Universuty of Medicine
Address
465 Kajii-cho,Kamigyo-ku,Kyoto city
Tel
0752515578
msasaki@koto.kpu-m.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
| 2018 | Year | 03 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective and retrospective study(Observational study)
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035455
