UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009814
Receipt number R000011501
Scientific Title Fundus imaging by Swept-source optical coherence tomography
Date of disclosure of the study information 2013/01/20
Last modified on 2013/01/19 22:28:22

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Basic information

Public title

Fundus imaging by Swept-source optical coherence tomography

Acronym

Fundus imaging by SS-OCT

Scientific Title

Fundus imaging by Swept-source optical coherence tomography

Scientific Title:Acronym

Fundus imaging by SS-OCT

Region

Japan


Condition

Condition

Macular disease, optic neuropathy, retinal disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the association between fundus findings of Swept-source OCT and pathologies.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To analyze the retinal layer structures and abnormal findings of eyes with ocular disease.

Key secondary outcomes



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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with macular disease, optic neuropathy, and retinal disease.

Key exclusion criteria

Patients with past history of side effect of mydriatic agent. Patients with narrow angle eyes.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagahisa Yoshimura

Organization

Kyoto University

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

Kawahara-cho 54, syogoin, sakyo-ku, Kyoto

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto University

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

Kawahara-cho 54, syogoin, sakyo-ku, Kyoto

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Ophthalmology and Visual Sciences, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

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

2013 Year 01 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Open public recruiting

Date of protocol fixation

2013 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2013 Year 01 Month 19 Day

Last modified on

2013 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011501


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name