UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035190 |
|---|---|
| Receipt number | R000040023 |
| Scientific Title | Study on clinical utility of optical coherence tomography angiography in retinal disease |
| Date of disclosure of the study information | 2018/12/09 |
| Last modified on | 2018/12/09 19:23:11 |
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Basic information
Public title
Study on clinical utility of optical coherence tomography angiography in retinal disease
Acronym
Utility of optical coherence angiography in retinal diseases
Scientific Title
Study on clinical utility of optical coherence tomography angiography in retinal disease
Scientific Title:Acronym
Utility of optical coherence angiography in retinal diseases
Region
| Japan |
Condition
Condition
diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, and other retinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the superiority and usefulness of Optical coherence tomography angiography(OCTA) in retinal imaging of the healthy retina and various retinal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of the OCTA imaging (retinal thickness, vessel density, foveal avascular zone, retinal nonperfused area, microaneurysms, retinal and choroidal neovascularization).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 diabetic retinopathy, retinal vein occlusion, and other retinal disease.
Key exclusion criteria
1. Patients who has an allergic reaction to mydriatic agent.Patients with glaucoma or narrow angle.
2. Patients with shallow anterior chamber.
3. Patients with severe cataract.
4. Patients who are not qualified as subjects for the study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koh-Hei Sonoda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5648
sonodak@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Nakao |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5660
Homepage URL
snakao@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2018 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Spatial pattern of vessel density was observed in eyes with diabetic retinopathy. Retinal nonperfused areas in eyes with diabetic retinopathy were quantitatively detected using OCTA.
Management information
Registered date
| 2018 | Year | 12 | Month | 09 | Day |
Last modified on
| 2018 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040023
