UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042306 |
|---|---|
| Receipt number | R000048299 |
| Scientific Title | Examination of eye diseases with adaptive op tics scanning laser ophthalmoscopy |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/31 16:28:34 |
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Basic information
Public title
Examination of eye diseases with adaptive op tics scanning laser ophthalmoscopy
Acronym
AO-SLO for eye disease
Scientific Title
Examination of eye diseases with adaptive op tics scanning laser ophthalmoscopy
Scientific Title:Acronym
AO-SLO for eye disease
Region
| Japan |
Condition
Condition
Diabetic retinopathy, age-related macular degeneration, retinitis pigmentosa, the other retinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine photoreceptor and retinal blood vessels in retinal diseases with AO-SLO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between cone mosaic, dynamic state of blood flow and visual function in retinal diseases
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
Adaptive Optics Scanning Laser Ophthalmoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patient group: Patients with diabetes retinopathy, age related macular degeneration, retina pigment denaturation, other retina disease s in Kyushu University Hospital ophthalmology. Control group: Person who do not have any retinal disease in Kyushu University Hospital ophthalmology, and there is not the systemic disease including diabetes and hypertension.
(2) Person who can understand this study plan enough, and the agreement by the person i s possible.
Key exclusion criteria
1) Person with the past which is a side effect (hyperesthesia and the eyes pressure rise) to mydriasis eye drop.
(2) Person with shallow anterior chamber
(3) Person who id judged that he is not suitable as a subject by a researcher.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koh-hei |
| Middle name | Kaizu |
| Last name | Sonoda |
Organization
Kyushu University
Division name
Ophthalmology
Zip code
812 8582
Address
3-1-1 Maidashi, Higashi-ku Fukuoka
TEL
81-92-642-5648
sonodak@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | Kaizu |
| Last name | Murakami |
Organization
Kyushu University
Division name
Ophthalmology
Zip code
812 8582
Address
3-1-1 Maidashi, Higashi-ku Fukuoka
TEL
81-92-642-5648
Homepage URL
ymuraka3@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Canon Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University
Address
3-1-1 Maidashi, Higashi-ku Fukuoka
Tel
81-92-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
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
| 2020 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 31 | Day |
Last modified on
| 2020 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048299
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
