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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040372
Receipt No. R000046076
Scientific Title Relationship between structure and function in early glaucoma
Date of disclosure of the study information 2020/05/12
Last modified on 2020/05/12

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Basic information
Public title Relationship between structure (retinal ganglion cell and vessel) and function (visual field) in early glaucoma
Acronym Relationship between structure (retinal ganglion cell and vessel) and function (visual field) in early glaucoma
Scientific Title Relationship between structure and function in early glaucoma
Scientific Title:Acronym Relationship between structure and function in early glaucoma
Region
Japan

Condition
Condition Glaucoma patient and Healthy volunteer
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the relationship between structure (retinal ganglion cell and retinal perfusion density) and function (visual field) in early glaucoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the proportion of cases that are inconsistent with those that follow the conventional order of abnormal appearance among the Humphrey visual field, Pulsar visual field, retinal ganglion cell thickness, peripapillary nerve fiber layer thickness, and macular and peripapillary retinal perfusion density and then to identify the factors associated with the discrepancy using a logistic multiple regression model.
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The participant who did not meet exclusion criteria.
Key exclusion criteria Glaucoma patient
(1) Corneal disease, retinal disease, diabetes, severe dry eye, and Emery-Little criteria 3 or higher.
(2) Corrected visual acuity less than 0.8.
(3) Refractive error exceeds spherical plus or minus 8D or astigmatism plus or minus 2D.
(4) Axial length exceeds 26.5 mm.
(5) IOP 30 mmHg or more.
(6) Fixation loss, false negatives, or false positives of 30% or more in Humphrey 24-2 or 30-2.
(7) MD less than -3dB with Humphrey 24-2 or 30-2.
(8) History of intraocular surgery other than the usual cataract surgery.
(9) The patient who have had refractive surgery including multi-focal IOL.

Healthy control
(1) Ophthalmic diseases that affect the visual field other than refractive error.
(2) Corrected visual acuity less than 0.8
(3) Refraction exceeds spherical power plus or minus 8D or astigmatism plus or minus 2D
(4) Axial length exceeds 26.5 mm.
(5) IOP 21 mmHg or more
(6) Fixation loss, false negatives, or false positives of 30% or more with Humphrey 24-2.
(7) Having a visual field abnormality that meets the Anderson criteria on the Humphrey 24-2
(8) History of refractive surgery
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name Hirasawa
Last name Shoji
Organization School of Medicine, Kitasato University
Division name Department of Ophthalmology
Zip code 2520373
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8464
Email nshoji@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name Hirasawa
Last name Hirasawa
Organization School of Medicine, Kitasato University
Division name Department of Ophthalmology
Zip code 2520373
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8464
Homepage URL
Email hirasawa@kitasato-u.ac.jp

Sponsor
Institute School of Medicine, Kitasato University
Institute
Department

Funding Source
Organization School of Medicine, Kitasato University
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 the Kitasato University Hospital Ethics Committee
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel 042-778-8273
Email rinrib@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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 12 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
2020 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 07 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 non

Management information
Registered date
2020 Year 05 Month 12 Day
Last modified on
2020 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046076

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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