UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045665 |
|---|---|
| Receipt number | 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 | 2022/07/06 13:27:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
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
| 2022 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052127
