UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050156 |
|---|---|
| Receipt number | R000057084 |
| Scientific Title | The research for patients scheduled for cataract surgery with blepharitis |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2023/01/23 14:45:12 |
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Basic information
Public title
The research for patients scheduled for cataract surgery with blepharitis
Acronym
The research for posterior blepharitis
Scientific Title
The research for patients scheduled for cataract surgery with blepharitis
Scientific Title:Acronym
The research for posterior blepharitis
Region
| Japan |
Condition
Condition
blepharitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate not only the prevalence of blepharitis but also the actual treatment status and efficacy for posterior blepharitis in patients scheduled for cataract surgery.
Basic objectives2
Others
Basic objectives -Others
To investigate not only the prevalence of blepharitis but also the actual treatment status and efficacy for posterior blepharitis in patients scheduled for cataract surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score changes in objective and subjective findings 4 weeks after treatment for posterior blepharitis
Key secondary outcomes
The prevalence of blepharitis
The bacteriological evaluation of meibum
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Blepharitis prevalence research
Those scheduled to undergo cataract surgery
Outpatient over 60 years old
2. Posterior blepharitis treatment research
Those who have obtained written consent of the research
Subjects with blepharitis, especially posterior blepharitis alone
Key exclusion criteria
None.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Frontier Medical Science and Technology for Ophthalmology
Zip code
602-0841
Address
450 Kajiicho, Hirokoji, Kawaramachi, Kamigyoku, Kyoto
TEL
+81(75)251-5772
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Prefectural University of Medicine
Division name
Department for Medical Innovation and Translational Medical Science
Zip code
602-0841
Address
465 Kajiicho, Hirokoji, Kawaramachi, Kamigyoku, Kyoto
TEL
+81(75)251-5308
Homepage URL
kimai@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
SENJU PHARMACEUTICAL CO., 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
IRB, Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Hirokoji, Kawaramachi, Kamigyoku, Kyoto
Tel
+81(75)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
京都府立医科大学附属病院（京都府）、京都市立病院（京都府）、バプテスト眼科クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
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 | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At first, we research the prevalence of blepharitis in 200 patients scheduled for cataract surgery. Next, we research the treatment status and efficacy of posterior blepharitis before cataract surgery in 50 patients scheduled for cataract surgery who were diagnosed with posterior blepharitis alone and judged to need antibiotics.
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057084
| 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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