UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031137
Receipt number R000035512
Scientific Title Evaluation of effectivness of the Eyelid clamper
Date of disclosure of the study information 2018/02/07
Last modified on 2018/07/17 11:06:21

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Basic information

Public title

Evaluation of effectivness of the Eyelid clamper

Acronym

Evaluation of effectivness of the Eyelid clamper

Scientific Title

Evaluation of effectivness of the Eyelid clamper

Scientific Title:Acronym

Evaluation of effectivness of the Eyelid clamper

Region

Japan


Condition

Condition

retinal disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of using Eyelidclamper while aquiring retinal image by the optos

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

area of the retina imaged using Eyelid clamper and optos

Key secondary outcomes

marginal reflex distance while applying the Eyelid clamper
corneal change after using Eyelid clamper


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients who visit Keio University Hospital ophthalmology department

Key exclusion criteria

corneal disease
patient who had eye surgery within 6 months
active infectious inflammation

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihide Kurihara

Organization

Keio University

Division name

School of Medicine, Department of Ophthalmology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

kurihara@z8.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuhiro Ozawa

Organization

Keio University

Division name

School of Medicine, Department of Ophthalmology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

n.ozw@z5.keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

YES

Study ID_1

20170235

Org. issuing International ID_1

Keio University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 07 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

Completed

Date of protocol fixation

2018 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

area of retinal image acquired by the Optos


Management information

Registered date

2018 Year 02 Month 04 Day

Last modified on

2018 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name