UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008237
Receipt number R000009709
Scientific Title Normal values of retinal sensitivity determined by macular integrity assessment
Date of disclosure of the study information 2012/06/25
Last modified on 2012/12/25 08:00:23

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Basic information

Public title

Normal values of retinal sensitivity determined by macular integrity assessment

Acronym

Normal values of retinal sensitivity

Scientific Title

Normal values of retinal sensitivity determined by macular integrity assessment

Scientific Title:Acronym

Normal values of retinal sensitivity

Region

Japan


Condition

Condition

Negative history for any ocular or systemic diseases.

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the retinal sensitivity of healthy subjects determined by Macular Integrity Assessment (MAIA), and to evaluate the relationship between retinal sensitivity and age in a group of subjects with a wide range of age. We also attempted to determine which factors were associated to retinal sensitivity when examined by MAIA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Retinal sensitivity,Visual acuity,Refractive error,Axial rength

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

5 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

criteria include a negative history of any ocular disease

Key exclusion criteria

oculae or sysstemic disease such as glaucoma, uveitis, retinal disease, diabetes melitus

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumio Shiraga

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Ophthalmology

Zip code


Address

1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Atushi Fujiwara

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Ophthalmology

Zip code


Address

1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Faculty of Medicine, Kagawa 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

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

2012 Year 06 Month 25 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

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the retinal sensitivity of health subjects determined by Macular Integrity Assessment.


Management information

Registered date

2012 Year 06 Month 23 Day

Last modified on

2012 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009709


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name