UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013589 |
|---|---|
| Receipt number | R000015688 |
| Scientific Title | Analysis of cornea using Heidelberg Retina Tomograph II Rostock Corneal Module |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/04/01 12:10:39 |
* 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
Analysis of cornea using Heidelberg Retina Tomograph II Rostock Corneal Module
Acronym
Analysis of cornea using Heidelberg Retina Tomograph II Rostock Corneal Module
Scientific Title
Analysis of cornea using Heidelberg Retina Tomograph II Rostock Corneal Module
Scientific Title:Acronym
Analysis of cornea using Heidelberg Retina Tomograph II Rostock Corneal Module
Region
| Japan |
Condition
Condition
Patients with corneal disease, Vogt-Koyanagi-Harada disease, and non corneal disease healthy volunteers
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze results of Heidelberg Retina Tomograph II Rostock Corneal Module for Patients with corneal disease, Vogt-Koyanagi-Harada disease, and non corneal disease healthy volunteers; and to evaluate the relation with corneal epithelial stem cell function
Basic objectives2
Others
Basic objectives -Others
1)Analysis of cell morphology of epithelium, stroma, and endothelium of central part of the cornea
2)Analysis of pigment cell density and cell morphology of cornea limbus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Analysis of cell morphology of epithelium, stroma, and endothelium of central part of the cornea
2)Analysis of pigment cell density and cell morphology of cornea limbus
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Observation of corneal limbus and central part of the cornea using Heidelberg Retina Tomograph II Rostock Corneal Module
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
1) Patients with corneal disease and Vogt-Koyanagi-Harada disease followed in Osaka University Hospital or non corneal disease healthy volunteers
2) Aged 20 years old and over
3) Written informed consent
Key exclusion criteria
Those who have been decided not appropriate for enrollment by the investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Oie |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3456
yoie@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Oie |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3456
Homepage URL
yoie@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015688
