UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024601
Receipt No. R000028305
Scientific Title Resilience of the ocular bacterial flora after ophthalmologic intervention with topical antibiotics
Date of disclosure of the study information 2016/10/30
Last modified on 2016/10/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Resilience of the ocular bacterial flora after ophthalmologic intervention with topical antibiotics
Acronym Study of long term observation of human conjunctival flora after perioperative topical antibiotics.
Scientific Title Resilience of the ocular bacterial flora after ophthalmologic intervention with topical antibiotics
Scientific Title:Acronym Study of long term observation of human conjunctival flora after perioperative topical antibiotics.
Region
Japan

Condition
Condition Patient underwent cataract surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of levofloxacin 1.5% ophthalmic solution to conjunctival flora after one month administration after cataract surgery
Basic objectives2 Others
Basic objectives -Others To investigate the change of bacteria isolates and antibiotics susceptibility of conjunctiva sac after the end of treatment of post-operative antibiotic ophthalmic solution
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Antibiotic susceptibility of isolated bacteria
(pre-operative, post ope 1, 3, 6, 9, 12 months)
Key secondary outcomes Change of antibiotic resistant
Bacterial prevalence in the conjunctiva flora.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with bacteria test within three months of cataract surgery.
2)Patients to obtain the consent
Key exclusion criteria 1)Patients with a history of antibiotics administration within three months prior to the study.
2)Patients with history of hypersensitivity or severe adverse effects against fluoroquinolones.
3)Glaucoma patients treated with ophthalmic solutions
4)Patients treated with steroid ophthalmic solutions
5)Patients treated with immunosuppressive agents
6)Patients suspecting any infectious ocular diseases.
7)Patients whom investigators considered not to be are eligible.
Target sample size 95

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

Public contact
Name of contact person
1st name
Middle name
Last name Ryohei Nejima
Organization Miyata eye Hospital
Division name Miyata eye Hospital
Zip code
Address 6-3 Kurahara Miyakonojo Miyazaki 885-0051
TEL 0986-22-1441
Homepage URL
Email nejima@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
Address
Tel
Email

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
2016 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
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, 9 and 12 months post-operative instillation of antibiotics. At nine months post-operation, samples were scraped from the upper eyelids.

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.