UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Resilience of the ocular bacterial flora after ophthalmologic intervention with topical antibiotics
Title of the study (Brief title)	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	Kazunori Miyata
Organization	Miyata eye Hospital
Division name	Miyata eye Hospital
Address	6-3 Kurahara Miyakonojo Miyazaki 885-0051
TEL	0986-22-1441
Email	miyata@miyata-med.ne.jp

Public contact
Name of contact person	Ryohei Nejima
Organization	Miyata eye Hospital
Division name	Miyata eye Hospital
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028305