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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005287
Receipt No. R000006278
Scientific Title Comparative study of human choroidal structure by different OCT machines
Date of disclosure of the study information 2011/03/22
Last modified on 2012/02/08

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Basic information
Public title Comparative study of human choroidal structure by different OCT machines
Acronym Choroidal structure by OCT
Scientific Title Comparative study of human choroidal structure by different OCT machines
Scientific Title:Acronym Choroidal structure by OCT
Region
Japan

Condition
Condition Normal eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To see the difference of choroidal sturucure examined by different OCT machines
Basic objectives2 Others
Basic objectives -Others Choroidal thickness measured by 3 different OCT mahcines
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Choroidal thickness measured by three different OCTs
Key secondary outcomes Difference of choroidal thickness based upon gender, age and other factors

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
18 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria normal eye
Key exclusion criteria Highly myopic eyes -5D or greater
Those of which fundus cannot be observed.
Those with apparent ocular diseases such as glaucoma, diabetic retinopathy, macular degenerations and others.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiji Sakamoto
Organization Kagoshima University
Division name Ophthalmology
Zip code
Address 8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL +81-99-275-5402
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Yamashita
Organization Kagoshima University
Division name Ophthalmology
Zip code
Address 8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL +81-99-275-5402
Homepage URL http://www.kufm.kagoshima-u.ac.jp/~op/gairai/RCstructurestudy.html
Email yyamatos@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Ophthalmology, Kagoshima Univ.
Institute
Department

Funding Source
Organization Ophthalmology, Kagoshima Univ.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 22 Day

Related information
URL releasing protocol http://www.kufm.kagoshima-u.ac.jp/~op/gairai/RCstructurestudy.html
Publication of results Published

Result
URL related to results and publications http://www.iovs.org/content/early/2012/01/10/iovs.11-8836.long
Number of participants that the trial has enrolled
Results Results:Forty-three subjects (mean age 30.5 years) were enrolled. Of 43 the eyes, SCT of 39 eyes (90.7%) could be measured using each machine. Intra-class correlation coefficients (95% confident interval) were 0.976 (0.954-9.987), 0.958 (0.919-0.978) and 0.939 (0.895-0.971) with Spectralis, Cirrus, and Topcon respectively. Inter-rater correlation coefficients (95% confident interval) were 0.944 (0.893 to 0.971), 0.956 (0.831 to 0.983) and 0.924 (0.825 to 0.964) with Spectralis, Cirrus, and Topcon respectively. The average SCT was 272.6, 272.8, and 269.2 &micro;m with Spectralis, Cirrus, and Topcon, respectively. Inter-machine correlation coefficient was significantly high among the machines (P<0.001, Spearman); 0.97 (Spectralis-Cirrus), 0.96 (Cirrus-Topcon) and 0.98 (Topcon-Cirrus). Bland-Altman plot analysis showed no typical trend among the machines.Conclusions:SCT measurements obtained with 3 different SD-OCTs were highly correlated and could be used interchangeably.
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
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information Comparison of results of choroidal thickness using several different OCT machines.

Publishsed as follows:

Repeatability and reproducibilityof subfoveal choroidal thickness in normal eyes of Japanese using different SD-OCT devices.
Yamashita T, Yamashita T, Shirasawa M, Arimura N, Terasaki H, Sakamoto T.

Invest Ophthalmol Vis Sci. 2012 Jan 12. [Epub ahead of print]

Management information
Registered date
2011 Year 03 Month 22 Day
Last modified on
2012 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006278

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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