UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005287 |
|---|---|
| Receipt number | 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 21:24:06 |
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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
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
yyamatos@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima Univ.
Institute
Department
Personal name
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
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 µm 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006278
