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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041741
Receipt No. R000046775
Scientific Title Microbiological investigation of the ocular surface flora in the patients with strabismus surgery and prophylactic antibiotic eye drops
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/09

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Basic information
Public title Microbiological investigation of the ocular surface flora in the patients with strabismus surgery and prophylactic antibiotic eye drops
Acronym Microbiological investigation of the ocular surface flora in the patients with strabismus surgery
Scientific Title Microbiological investigation of the ocular surface flora in the patients with strabismus surgery and prophylactic antibiotic eye drops
Scientific Title:Acronym Microbiological investigation of the ocular surface flora in the patients with strabismus surgery
Region
Japan

Condition
Condition strabismus
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Longitudinal changes in ocular surface flora after 1.5% LVFX eye drops in the perioperative period of strabismus
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preoperatively, at the end of postoperative antimicrobials, 3 months after the end of antimicrobials, and 6 months after the end of antimicrobials, the conjunctival sac was abraded and anaerobic Culture. Determine MICs for the identified epidermal staphylococci.
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 1)Patients with pre- and post-operative antibiotics administration to prevent post-operative infection
2)Patients in capable to obtain the consent from the patients or their parents/gurdians
Key exclusion criteria 1)Patients suspicious for bacterial, fungal or viral infections.
2)Patients with a history of antibiotics administration and immunosuppressive agents and steroid within three months prior to the operations.
3)Patients whom the investigators considered not to be are eligible.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazunori
Middle name
Last name Miyata
Organization Miyata eye Hospital
Division name Miyata eye Hospital
Zip code 885-0051
Address 6-3 Kurahara Miyakonojo Miyazaki
TEL 0986-22-1441
Email kaida@miyata-med.ne.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kaida
Organization Miyata eye Hospital
Division name Miyata eye Hospital
Zip code 885-0051
Address 6-3 Kurahara Miyakonojo Miyazaki
TEL 0986-22-1441
Homepage URL
Email kaida@miyata-med.ne.jp

Sponsor
Institute Miyata eye Hospital
Institute
Department

Funding Source
Organization none
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 Miyata eye Hospital
Address 6-3 Kurahara Miyakonojo Miyazaki
Tel 0986-22-1441
Email ushihama@miyata-med.ne.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
2020 Year 09 Month 10 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
2020 Year 04 Month 13 Day
Date of IRB
2020 Year 04 Month 23 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Bacteriologic examination was performed on samples scraped from the conjunctival sac under surface anesthesia with preservative-free oxybuprocaine hydrochloride before the start of topical LVFX, at 0 (after the last LVFX), 3, 6 months post-operative instillation of antibiotics.

Management information
Registered date
2020 Year 09 Month 09 Day
Last modified on
2020 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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