UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2020 Year 04 Month 10 Day
Date of IRB	2020 Year 07 Month 09 Day
Anticipated trial start date	2020 Year 07 Month 10 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	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046076