UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039532
Receipt number R000017470
Scientific Title Objective evaluation by functional near-infrared spectroscopy(fNIRS) of the relationship between color tone and photophobia in patients with the eye diseases.
Date of disclosure of the study information 2020/03/01
Last modified on 2021/08/24 19:32:49

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Objective evaluation by functional near-infrared spectroscopy(fNIRS) of the relationship between color tone and photophobia in patients with the eye diseases.

Acronym

Objective evaluation of photophobia.

Scientific Title

Objective evaluation by functional near-infrared spectroscopy(fNIRS) of the relationship between color tone and photophobia in patients with the eye diseases.

Scientific Title:Acronym

Objective evaluation of photophobia.

Region

Japan


Condition

Condition

Retinal degeneration group (including retinitis pigmentosa), eyelid and facial muscle spasm group (including hemifacial spasm and blepharospasm), ocular surface disorder group (including dry eye), and nerve atrophy group (including advanced glaucoma).

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objective quantitative evaluation of photophobia, a symptom that occurs in various pathologies, is difficult. Previously we objectively evaluated photophobia in normal subjects under mydriasis with light load by assessing frontal lobe activation by fNIRS (functional near infrared spectroscopy) and physiological changes in blink frequency while adjusting light load by changing color filters. In this study, we evaluated whether photophobia in patients with the eye diseases could be assessed by this method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Objective quantitative evaluation of photophobia.

Key secondary outcomes

Determination of photophobia reduce color by each disease.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Frontal lobe activation measurement using fNIRS (functional near-infrared spectroscopy) under four conditions with 1000 lx light load for 1.5 minutes.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Retinal degeneration group (including retinitis pigmentosa), eyelid and facial muscle spasm group (including hemifacial spasm and blepharospasm), ocular surface disorder group (including dry eye), and nerve atrophy group (including advanced glaucoma) with photophobia.

Key exclusion criteria

Unstable medical condition
Unmeasurable
Eyelid opening impossible in light load of 1000 lx
Expected of phototoxic
Obvious misalignment of the eyes
If you think researchers unsuitable

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Ono

Organization

Nippon Medical School

Division name

Department of Ophthalmology

Zip code

1138603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN

TEL

0338222131

Email

ono@nms.ac.jp


Public contact

Name of contact person

1st name Masafumi
Middle name
Last name Ono

Organization

Nippon Medical School

Division name

Department of Ophthalmology

Zip code

1138603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN

TEL

03-3822-2131

Homepage URL


Email

ono@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Tokai Optical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nippon Medical School

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 JAPAN

Tel

03-3822-2131

Email

inq-ccr@nms.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



Other administrative information

Date of disclosure of the study information

2020 Year 03 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

33

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

2012 Year 11 Month 01 Day

Date of IRB

2013 Year 04 Month 10 Day

Anticipated trial start date

2013 Year 04 Month 10 Day

Last follow-up date

2020 Year 08 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 02 Month 19 Day

Last modified on

2021 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017470


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name