UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022770 |
|---|---|
| Receipt number | R000026242 |
| Scientific Title | Characteristics of Hyperautofluorescent Choroidal Vessels Using Fundus Camera Type Short-wavelength Autofluorescence |
| Date of disclosure of the study information | 2016/07/14 |
| Last modified on | 2019/03/05 19:41:12 |
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Basic information
Public title
Characteristics of Hyperautofluorescent Choroidal Vessels Using Fundus Camera Type Short-wavelength Autofluorescence
Acronym
Hyperautofluorescent choroidal vessels
Scientific Title
Characteristics of Hyperautofluorescent Choroidal Vessels Using Fundus Camera Type Short-wavelength Autofluorescence
Scientific Title:Acronym
Hyperautofluorescent choroidal vessels
Region
| Japan |
Condition
Condition
Normal eyes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify characteristics of hyperautofluorescent choroidal vessels using fundus autofluorescence with an excitation wavelength over 520nm.
Basic objectives2
Others
Basic objectives -Others
Hyperautofluorescent choroidal vessels in both nasal and temporal portions of the same eye (group 1) and only in the nasal portion of the same eye (group 2) were studied.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Choroidal and retinal thicknesses (at the fovea, nasal and temporal portions 3,000 micrometer from the fovea) were compared between the two groups.
Key secondary outcomes
Axial length and refractive error were compared between groups.
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
| 40 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eyes with hyperautofluorescent choroidal vessels in either the nasal only or both nasal and temporal portions. Images were obtained with a fundus camera type and axial length measurements were obtained retrospectively from medical records.
Key exclusion criteria
Eyes with age-related macular degeneration, epiretinal membrane, macular hole and other ocular fundus disorders were excluded.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ari Shinojima |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
Address
1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
+81332931711
shinojima.ari@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ari Shinojima |
Organization
Nihon University School of Medicine
Division name
Division of Ophthalmology, Department of Visual Sciences
Zip code
Address
1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
+81332931711
Homepage URL
shinojima.ari@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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 | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/27614990
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27614990
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
| 2016 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In group 1 (n=19), the average foveal, nasal, and temporal choroidal thicknesses were 69, 57, and 88 micrometer, refractive error was -10D, axial length 28mm, and the average foveal, nasal, and temporal retinal thicknesses were 170, 222, and 209 micrometer. In group 2 (n=17), the respective values were 175, 80, 174 micrometer, -2D, 24mm, 213, 278, and 253 micrometer. There were significant between group differences for all items (p<0.05) except age.
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026242
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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