UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031499 |
|---|---|
| Receipt number | 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 | 2020/12/02 14:36:48 |
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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
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
mineo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 02 | Day |
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
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035958
