UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010586 |
|---|---|
| Receipt number | R000012369 |
| Scientific Title | Studies on the clinical usefulness of high-resolution optical coherence tomography |
| Date of disclosure of the study information | 2013/04/24 |
| Last modified on | 2014/01/07 22:49:01 |
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Basic information
Public title
Studies on the clinical usefulness of high-resolution optical coherence tomography
Acronym
high-resolution optical coherence tomography
Scientific Title
Studies on the clinical usefulness of high-resolution optical coherence tomography
Scientific Title:Acronym
high-resolution optical coherence tomography
Region
| Japan |
Condition
Condition
patients with retinal disease or glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of newly developed high-resolution optical coherence tomography in patients with retinal disease and glaucoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the resolution of retinal or optic nerve lesions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To test a newly developed high-resolution optical coherence tomography in 50 patients
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 with retinal disease or glaucoma
Key exclusion criteria
patients of age younger than 20 years
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Hospital
Division name
ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5027
mineo@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Hospital
Division name
Ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5027
Homepage URL
mineo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
三重大学病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 24 | 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
| 2013 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2014 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012369
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
