UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018590 |
|---|---|
| Receipt number | R000021520 |
| Scientific Title | Evaluation of the difference between enophthalmos of both eyes in the patients who are treated unilaterally with ophthalmic solution for glaucoma |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2019/03/11 21:32:16 |
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Basic information
Public title
Evaluation of the difference between enophthalmos of both eyes in the patients who are treated unilaterally with ophthalmic solution for glaucoma
Acronym
Evaluation of the difference between enophthalmos of both eyes in the patients with glaucoma
Scientific Title
Evaluation of the difference between enophthalmos of both eyes in the patients who are treated unilaterally with ophthalmic solution for glaucoma
Scientific Title:Acronym
Evaluation of the difference between enophthalmos of both eyes in the patients with glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the difference between enophthalmos of both eyes in the patients who are treated unilaterally with ophthalmic solution for glaucoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between enophthalmos of both eyes
Key secondary outcomes
The difference between volumes of orbital fatty tissue of both eyes
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 who are already treated unilaterally with prostaglandin ophthalmic solution
Key exclusion criteria
Patients who can not undergo MRI examination
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Higashiyama |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL
0775482276
higashi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Higashiyama |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL
0775482276
Homepage URL
higashi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Scholarship donations
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
| 2015 | Year | 08 | Month | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
analytical epidemiology/cross-sectional method
Sampling:Consecutive cases
Management information
Registered date
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021520
