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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045665
Receipt No. R000052127
Scientific Title Constructing the reliability criteria for static perimetry in visual impairment criteria for determination
Date of disclosure of the study information 2021/12/01
Last modified on 2021/10/05

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Basic information
Public title Constructing the reliability criteria for static perimetry in visual impairment criteria for determination
Acronym Constructing the reliability criteria for static perimetry in visual impairment criteria for determination
Scientific Title Constructing the reliability criteria for static perimetry in visual impairment criteria for determination
Scientific Title:Acronym Constructing the reliability criteria for static perimetry in visual impairment criteria for determination
Region
Japan

Condition
Condition Patints with visual field defect
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the characteristics of variability in Estermann test and 10-2 program in patints with various visual acuity and visual field defet and calcurate the reliability criteria for Estermann test and 10-2 program in patients who apply the visual impairment criteria for determination.
Basic objectives2 Others
Basic objectives -Others Same as objectives2
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identifing the factors related to the variabiity in Estermann test and 10-2 program and calculating the cut-off value of the factors related to the variability.
Key secondary outcomes (1) Effect of the better or worse eye on the variability.
(2) The visual acuity which static visual field measurements can be performed.
3) Relationship between fovea threshold and visual acuity
(4) Minimum retinal capillary density and diameter.

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Meaurering two additional binocular open Esterman tests.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing 10-2 program visual field testing for medical purposes
Key exclusion criteria (1) Patients who are unable to make their own decision to participate in the study
(2) Patients who have been diagnosed as normal with no visual field abnormalities.
3) Patients under 20 years old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Shoji
Organization Kitasato University School of Medicine
Division name Department of Ophthalmology
Zip code 2520374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8464
Email nshoji@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Hirasawa
Organization Kitasato University School of Medicine
Division name Department of Ophthalmology
Zip code 042-778-8464
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-7967
Homepage URL
Email hirasawa@kitasato-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Kitasato University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Research Ethics Committee of the Kitasato University Hospital
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel 0427788273
Email rinri@med.kitasato-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 北里大学病院眼科外来

Other administrative information
Date of disclosure of the study information
2021 Year 12 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2023 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
2021 Year 10 Month 05 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052127

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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