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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033262
Receipt No. R000037916
Official scientific title of the study A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/04

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Basic information
Official scientific title of the study A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Title of the study (Brief title) 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 Tomoko Naito
Organization Okayama Univ. Hospital
Division name Ophthalmology
Address 2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL 086-235-7297
Email tomokoum@gmail.com

Public contact
Name of contact person Takako Miki
Organization Okayama Univ. Hospital
Division name Ophthalmology
Address 2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL 086-235-7297
Homepage URL
Email higo_oka@yahoo.co.jp

Sponsor
Institute Okayama Univ. Hospital
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 22 Day
Anticipated trial start date
2018 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037916

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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