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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022770
Receipt No. 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

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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
Email 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
Email shinojima.ari@nihon-u.ac.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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