UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024601 |
|---|---|
| Receipt number | 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 08:43:04 |
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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
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
nejima@miyata-med.ne.jp
Sponsor or person
Institute
Miyata eye Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028305
