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

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 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


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

Value
https://center6.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