UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028432
Receipt number R000032531
Scientific Title Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration
Date of disclosure of the study information 2017/07/28
Last modified on 2019/04/03 12:09:22

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Basic information

Public title

Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration

Acronym

transcorneal electrical stimulation test

Scientific Title

Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration

Scientific Title:Acronym

transcorneal electrical stimulation test

Region

Japan


Condition

Condition

retinal degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Consideration for Assessment of function of remaining inner retina

Basic objectives2

Others

Basic objectives -Others

Assessment of function of remaining inner retina

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Threshold of transcorneal electrical stimulation

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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

day -180 ~ 0: informed consent and patient background
day 0: transcorneal electrical stimulation test
day 30: follow up visit

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

25 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.retinitis pigmentosa
2.hand motion, light perception, or no light perception.
3.loss of ERG potential

Key exclusion criteria

1.other ocular diseases
2.retinal tumor
3.brain tumor, brain attack

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujikado

Organization

Osaka University Graduate School of Medicine

Division name

Department of Applied Visual Science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka-pref.

TEL

06-6879-3941

Email

fujikado@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Fujikado

Organization

Osaka University Graduate School of Medicine

Division name

Department of Applied Visual Science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka-pref.

TEL

06-6879-3941

Homepage URL


Email

fujikado@ophthal.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2017 Year 07 Month 28 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

2017 Year 05 Month 30 Day

Date of IRB

2017 Year 04 Month 30 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2019 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

2017 Year 07 Month 28 Day

Last modified on

2019 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032531


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name