UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012481 |
|---|---|
| Receipt number | R000014614 |
| Scientific Title | Ultra-Widefield Fluorescein Angiography by Oral Administration of Fluorescein |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2013/12/04 02:03:12 |
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Basic information
Public title
Ultra-Widefield Fluorescein Angiography
by Oral Administration of Fluorescein
Acronym
Oral-UWFA
Scientific Title
Ultra-Widefield Fluorescein Angiography
by Oral Administration of Fluorescein
Scientific Title:Acronym
Oral-UWFA
Region
| Japan |
Condition
Condition
Diabetic retinopathy, retinal vein occulusion, uveites
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Optos ultra-widefield (UWF) imaging system (Optos Panoramic 200TX, Optos PLC. Dunfermline, Scotland, UK) can image 200 degree of the retina in one frame and also be used for fluorescein angiography (FA) with same wide angle. We present findings with UWF-FA using the Optos after an oral fluorescein administration to avoid various systemic and local complications with a conventional intravenous fluorescein injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Existence of side effects and usefulness
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Those who received oral UWF-FA
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
Those patients with diabetic retinopathy, retinal vein occlusion and uveites are recruited.
Key exclusion criteria
Exclusion criteria are patients who have history of fluorescein allergy, liver function failure, abnormal hypertension, cerebral vascular disorder, pregnant and minority.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
059-231-5027
Sugimochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
059-231-5027
Homepage URL
Sugimochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
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 | 12 | Month | 04 | 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 | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 04 | Day |
Last modified on
| 2013 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014614
