UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023960 |
|---|---|
| Receipt number | R000027489 |
| Scientific Title | The development of a new method for evaluation of glaucoma (The relationship between ocular circulation and neural activity in glaucoma patients) |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2017/06/20 00:01:29 |
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Basic information
Public title
The development of a new method for evaluation of glaucoma (The relationship between ocular circulation and neural activity in glaucoma patients)
Acronym
The relationship between ocular circulation and neural activity in glaucoma patients
Scientific Title
The development of a new method for evaluation of glaucoma (The relationship between ocular circulation and neural activity in glaucoma patients)
Scientific Title:Acronym
The relationship between ocular circulation and neural activity in glaucoma patients
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between the ocular circulation and neural activity in glaucoma patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow alteration in response to flicker stimuli
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
Flickering Stimuli
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects able to understand the written informed consent and willing to participate evidenced by signing the informed consent
Control
1)Normal intraocular pressure, open-angle
2)No glaucomatous changes in the fundus
Glaucoma
1)Glaucomatous changes in the fundus
2)Abnormal glaucomatous visual field according to the Anderson-Patella classification in the Swedish interactive threshold algorithm (SITA)-standard strategy of the 30-2 program of the Humphrey field analyzer (HFA)
Key exclusion criteria
1)Cataract and previous cataract surgery
2)High ametropia
3)Subjects with cardiovascular disease such as untreated hypertension and diabetes mellitus
4)Previous ocular surgery
5)Difficulty for perform examination
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Kamiya |
Organization
Asahikawa Medical University
Division name
Ophthalmology
Zip code
Address
2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2543
t-kamiya@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Kamiya |
Organization
Asahikawa Medical University
Division name
Ophthalmology
Zip code
Address
2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2543
Homepage URL
t-kamiya@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
| 2016 | Year | 09 | Month | 12 | 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
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | 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
| 2016 | Year | 09 | Month | 06 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027489
| 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 |
