UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017504 |
|---|---|
| Receipt number | R000020291 |
| Scientific Title | Assessment of short-term changes in optic nerve head hemodynamics in hyperoxic conditions with Laser Speckle Flowgraphy in eyes with glaucoma |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/05/11 18:44:48 |
* 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
Assessment of short-term changes in optic nerve head hemodynamics in hyperoxic conditions with Laser Speckle Flowgraphy in eyes with glaucoma
Acronym
Ocular blood flow alterztions in response to hyperoxia in eyes with glaucoma
Scientific Title
Assessment of short-term changes in optic nerve head hemodynamics in hyperoxic conditions with Laser Speckle Flowgraphy in eyes with glaucoma
Scientific Title:Acronym
Ocular blood flow alterztions in response to hyperoxia in eyes with glaucoma
Region
| Japan |
Condition
Condition
Glaucoma and control (cataract, perimacular fibrosis, macular hole, dry eye)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate ocular blood flow alteration in response to hyperoxia
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow alteration in response to
hyperoxia
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
inhalasion of pure oxygen
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) glaucomatous change in optic disc
2) glaucomatous visual field in at least twice examinations
3) open angle
4) normal range of diopter within +3.0D to -8D
Key exclusion criteria
1) Subjects with severe respitatory and cardiovascular disease
2) Subjecys with pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7294
Homepage URL
kunikata@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine,department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
KAKENHI Grants-in-Aid for Scientific Research (B)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 22 | 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
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020291
