UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030543 |
|---|---|
| Receipt number | R000034574 |
| Scientific Title | The analysis of the shape of anterior cornea based on the new corneal topography for ocular surface disease. |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2020/12/26 14:18:55 |
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Basic information
Public title
The analysis of the shape of anterior cornea based on the new corneal topography for ocular surface disease.
Acronym
The analysis of the shape of anterior cornea for ocular surface disease.
Scientific Title
The analysis of the shape of anterior cornea based on the new corneal topography for ocular surface disease.
Scientific Title:Acronym
The analysis of the shape of anterior cornea for ocular surface disease.
Region
| Japan |
Condition
Condition
Ocular surface disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the ability of the new corneal topography for diagnosing and grading values for ocular surface disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Several parameters derived from the shape of Meyer ring measured by topography with built-in software were evaluated and compared with the results of the other examination.
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
RET-7000 Corneal topography was performed single time at the only day they 1st arrived. RET-7000 performed in less than one minute as non invasive, non contact imaging system.
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
This study involved the patients who visited Kyoto Prefectural University of medicine between the day of approval and December 2019.
All eyes were diagnosed as ocular surface disease.The patient who can agree with the consent form of this study was included.
Key exclusion criteria
The patient who judged as Inappropriate for this study by ophthalmologist were not included.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | itoi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-8566
Address
465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
TEL
0752515578
mope@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | itoi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-8566
Address
465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
TEL
075-251-5578
Homepage URL
mope@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2019 | Year | 12 | Month | 31 | 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
50
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034574
