UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033262 |
|---|---|
| Receipt number | R000037916 |
| Scientific Title | A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2019/08/20 17:35:25 |
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Basic information
Public title
A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Acronym
A comparison of 'imo' with Humphrey
Scientific Title
A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Scientific Title:Acronym
A comparison of 'imo' with Humphrey
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the results of the detecting glaucomatous visual field defects between 'imo' and Humphrey
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement with MD values of 'imo' and Humphrey perimeter
Key secondary outcomes
Test time for the two perimeters
Fixation of eyes during the test for the two perimeters
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with glaucomatous visual field damage
Test visual field with Humphrey
Patients who are willing to participate in the study, and who are able to provide written informed consent
Patients able to visit the medical institution at pre-defined visits
Key exclusion criteria
MD value of Humphrey < -30dB
Patients who show best corrected decimal visual acuity less than 0.1
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Naito |
Organization
Okayama Univ. Hospital
Division name
Ophthalmology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL
086-235-7297
tomokoum@gmail.com
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Miki |
Organization
Okayama Univ. Hospital
Division name
Ophthalmology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL
086-235-7297
Homepage URL
higo_oka@yahoo.co.jp
Sponsor or person
Institute
Okayama Univ. Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
700-8558 2-5-1 Shikata-cho Kita-ku Okayama city
Tel
086-235-6503
mae6605@adm.okayama-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
| 2018 | Year | 07 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study duration:from 2018/6 to 2021/6
Subjects:All subjects that our hospital visited by glaucoma, and met the selection criteria.
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037916
