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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031499
Receipt No. R000035958
Scientific Title Comparative study of ultra-high resolution OCT and conventional OCT
Date of disclosure of the study information 2018/02/27
Last modified on 2018/02/27

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Basic information
Public title Comparative study of ultra-high resolution OCT and conventional OCT
Acronym Comparative study of ultra-high resolution OCT and conventional OCT
Scientific Title Comparative study of ultra-high resolution OCT and conventional OCT
Scientific Title:Acronym Comparative study of ultra-high resolution OCT and conventional OCT
Region
Japan

Condition
Condition Normal, retinal disease and glaucoma
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the agreement and precision between the ultra-high resolution OCT and the conventional OCT for full retinal thickness, retinal nerve fiber layer thickness and ganglion cell complex thickness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Agreement and precision for full retinal thickness, retinal nerve fiber layer thickness and ganglion cell complex thickness.
Key secondary outcomes

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Qualifying examination and retinal tomogram data acquisition in a day.
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

Not applicable
Gender Male and Female
Key inclusion criteria Normal
1. Subjects who have been diagnosed with normal with normal eye examinations.
2. Subjects able to keep sitting position by themselves for approximately 30 seconds of one measurement and approximately 15 - 20 minutes of whole measurement.
3. Subjects who agree to participate in this study and sign the informed consent form.

Retinal disease and glaucoma
1. Subjects who have been diagnosed with retinal disease or glaucoma with normal eye examinations.
2. Subjects able to keep sitting position by themselves for approximately 30 seconds of one measurement and approximately 15 - 20 minutes of whole measurement.
3. Subjects who agree to participate in this study and sign the informed consent form.
Key exclusion criteria 1. Subjects unable to follow fixation.
2. Subjects with cataract unable to measure.
3. Subjects who have medical history for a side effect by using a mydriatic agent.
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie
TEL 059-231-5027
Email mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie
TEL 059-231-5027
Homepage URL
Email mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kowa Company, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 27 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035958

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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