UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040372 |
|---|---|
| Receipt number | R000046076 |
| Scientific Title | Relationship between structure and function in early glaucoma |
| Date of disclosure of the study information | 2020/05/12 |
| Last modified on | 2022/02/08 07:08:13 |
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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
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
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
School of Medicine, Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046076
