UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046685 |
|---|---|
| Receipt number | R000053252 |
| Scientific Title | Statistical Analysis of Treatment Outcomes for Keratoconjunctival Diseases - Observational Study Using Medical Records (Comprehensive Study) |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/01/21 08:18:00 |
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Basic information
Public title
A study to analyze the outcomes of treatment for keratoconjunctival diseases
Acronym
Study of corneoconjunctival diseases using medical records
Scientific Title
Statistical Analysis of Treatment Outcomes for Keratoconjunctival Diseases - Observational Study Using Medical Records (Comprehensive Study)
Scientific Title:Acronym
A Comprehensive Study of Corneal and Conjunctival Diseases Using Medical Records
Region
| Japan |
Condition
Condition
Corneal and Conjunctival Diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In ocular diseases, imaging tests are directly related to diagnosis and treatment, and serve as an index for evaluating visual function. The purpose of this study was to compare the results of various tests, including imaging tests, before and after treatment of patients diagnosed with keratoconjunctival disease, and to find the relationship between the results and treatment outcomes.
Basic objectives2
Others
Basic objectives -Others
Examine the factors that influence the onset and treatment of disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors Affecting the Prognosis of Keratoconjunctival Disease
Key secondary outcomes
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
None.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mie University
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-1111
k-kato@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mie University
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
k-kato@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Center for Clinical Research and Development, Mie University Hospital
Address
2-174,Edobashi,Tsu, Mie, Japan
Tel
0592315246
kk-sien@med.mie-u.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
| 2022 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate variations in data before and after treatment for corneoconjunctival disease. Evaluate for the presence of systemic disease in addition to ophthalmologic test results.
Management information
Registered date
| 2022 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
