UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029493 |
|---|---|
| Receipt number | R000033094 |
| Scientific Title | Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops.. |
| Date of disclosure of the study information | 2017/10/12 |
| Last modified on | 2017/10/10 16:07:35 |
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Basic information
Public title
Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Acronym
Comparison between intaraoperative iodine and preoperative antibiotic drops.
Scientific Title
Comparison of the cleanliness of the operative field in cataract surgery between intraoperative iodine and preoperative antibiotic drops..
Scientific Title:Acronym
Comparison between intaraoperative iodine and preoperative antibiotic drops.
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the hypothesis that the intraoperative iodine application attains the efficient cleanliness of the operative field during the
cataract surgery without preoperative antibiotic eyedrops.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The copy number of the polymerase chain reaction and bacterial flora amount of the operative field in cataract surgery.
Key secondary outcomes
vision
grade of flare
endophthalmitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Former eye: Intraoperative iodine compound disinfection for surgical field without preoperative antibiotics
Interventions/Control_2
Second eye: Preoperative antibiotic application without intraoperative iodine disinfection.
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 undergoing cataract surgery.
Key exclusion criteria
Patients with pre-existing blepharitis, conjunctivitis, keratitis, or uveitis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kauki Matsuura |
Organization
NOjimahospital
Division name
Ophthalmology
Zip code
Address
2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL
0858-22-6231
matsu224@ncn-k.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kauki Matsuura |
Organization
NOjimahospital
Division name
Ophthalmology
Zip code
Address
2514-1, Sezaki-cho, Kurayoshi, Tottori
TEL
0858-22-6231
Homepage URL
matsu224@ncn-k.net
Sponsor or person
Institute
Nojima hospital
Institute
Department
Personal name
Funding Source
Organization
Nojima hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 10 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033094
