UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042305
Receipt number R000048298
Scientific Title Examination of normal photoreceptor using adaptive optics scanning laser ophthalmoscopy
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/31 15:42:19

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Basic information

Public title

Examination of normal photoreceptor using adaptive optics scanning laser ophthalmoscopy

Acronym

AO-SLO for normal eye

Scientific Title

Examination of normal photoreceptor using adaptive optics scanning laser ophthalmoscopy

Scientific Title:Acronym

AO-SLO for normal eye

Region

Japan


Condition

Condition

healthy eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine cone mosaic and blood vessel in healthy retina with AOSLO

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Characteristics of cone photoreceptors and retinal capillaries

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Adaptive Optics Scanning Laser Ophthalmoscope

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Healthy person who can agree by himself and understands sufficiently about this research plan.
(2) Person who can expire and get the consent by which less than 20 years old are your family and oneself

Key exclusion criteria

(1) Person with the past which is a side effect (hyperesthesia and the eyes pressure rise) to dilating drop
(2) Person with shallow anterior chamber
(3) Person who is judged that he is not suitable as a subject by a researcher

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Koh-hei
Middle name Kaizu
Last name Sonoda

Organization

Kyushu University

Division name

Department of Ophthalmology

Zip code

812-8582

Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

81-92-642-5648

Email

sonodak@med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Murakami

Organization

Kyushu University

Division name

Department of Ophthalmology

Zip code

812-8582

Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

81-92-642-5648

Homepage URL


Email

ymuraka3@med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Canon Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Canon Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University

Address

3-1-1 Maidashi Higashi-ku Fukuoka

Tel

81-92-642-5082

Email

byskenkyu@jimu.kyushu-u.ac.jp


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

九州大学病院


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 01 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

Enrolling by invitation

Date of protocol fixation

2020 Year 10 Month 23 Day

Date of IRB

2020 Year 10 Month 23 Day

Anticipated trial start date

2020 Year 10 Month 23 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 31 Day

Last modified on

2020 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name