UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045942 |
|---|---|
| Receipt number | R000052439 |
| Scientific Title | A Multicenter Observational Study on the Incidence of Infectious Endophthalmitis, Changes in Pathogenesis, and Visual Prognosis in Covid-19 pandemic period |
| Date of disclosure of the study information | 2021/11/02 |
| Last modified on | 2021/12/14 18:34:24 |
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Basic information
Public title
A Multicenter Observational Study on the Incidence of Infectious Endophthalmitis, Changes in Pathogenesis, and Visual Prognosis in COVID-19 pandemic period
Acronym
Investigation of the incidence of endophthalmitis in the COVID-19 pandemic period
Scientific Title
A Multicenter Observational Study on the Incidence of Infectious Endophthalmitis, Changes in Pathogenesis, and Visual Prognosis in Covid-19 pandemic period
Scientific Title:Acronym
Investigation of the incidence of endophthalmitis in the COVID-19 pandemic period
Region
| Japan |
Condition
Condition
Endophthalmitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of wearing masks and refraining from hospital visits on the incidence, causative organisms, and prognosis of endophthalmitis, and to analyze factors that affect treatment outcomes and visual prognosis.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of endophthalmitis before and after COVID-19 pandemic period.
Key secondary outcomes
Background of patients with endophthalmitis before and after COVID-19 period and its comparison, Examination of patient background that influences the pathogenesis of endophthalmitis before and after COVID-19 period, Examination of factors that influence visual prognosis.
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
Patients diagnosed with endophthalmitis and treated for endophthalmitis at the Department of Ophthalmology, Kagoshima University Hospital, and other facilities participating in the study between January 1, 2019, and June 30, 2021
Key exclusion criteria
not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Ophthalmology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Ophthalmology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
099-275-5402
Homepage URL
tsakamot@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
J
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
Tel
099-275-5111
isgskkrs@kuas.kagoshima-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
Japan Clinical Retina Study (J-CREST) group, Japan Reina and Vitreous Society (JRVS)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052439
