UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026745 |
|---|---|
| Receipt number | R000030705 |
| Scientific Title | Prospective study of ocular surface diseases |
| Date of disclosure of the study information | 2017/03/28 |
| Last modified on | 2017/03/28 20:28:28 |
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Basic information
Public title
Prospective study of ocular surface diseases
Acronym
Prospective study of ocular surface diseases
Scientific Title
Prospective study of ocular surface diseases
Scientific Title:Acronym
Prospective study of ocular surface diseases
Region
| Japan |
Condition
Condition
Ocular surface diseases
Classification by specialty
| Ophthalmology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical factors post treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
Corneal endothelial density, Central corneal thickness, Severity of conjunctival injection, foveal thickness, cytokine in anterior chamber
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Post treatment for ocular surface diseases
Key exclusion criteria
Patients who disagree to be involved in the study
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Inatomi |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
Address
465 Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL
075-251-5578
tinatomi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kitazawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
Address
465 Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL
075-251-5578
Homepage URL
kkitazaw@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
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
| 2017 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
visual acuity
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030705
