UMIN-CTR Clinical Trial

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
Email	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
Email	tsakamot@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052439