UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050791 |
|---|---|
| Receipt number | R000057876 |
| Scientific Title | Iodine compound as postoperative eye drop following cataract surgery |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2023/04/09 08:43:58 |
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Basic information
Public title
Iodine compound as postoperative eye drop following cataract surgery
Acronym
Iodine compound as postoperative eye drop following cataract surgery
Scientific Title
Iodine compound as postoperative eye drop following cataract surgery
Scientific Title:Acronym
Iodine compound as postoperative eye drop following cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
there is a concern about the risk of resistant bacteria when using postoperative antibiotic eye drops. Our study will verify whether safe management can be achieved by iodine eye drops without the risk of resistant bacteria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in minimum inhibitory concentration of local bacteria in the eye 1 week and 1 month following surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Comparison of antibiotics and Iodine following cataract surgery
using eye drops 3days a day for 1 week
Interventions/Control_2
Comparison of antibiotics and Iodine following cataract surgery
using eye drops 3days a day for 1 week
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for cataract surgery
Key exclusion criteria
Patients using antibiotics within 3 months before surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kazuki |
| Middle name | |
| Last name | matsuura |
Organization
nojima hospital
Division name
ophthalmology
Zip code
682-0863
Address
2714-1 sesakimachi kurayosi
TEL
0858226231
matsu224@ncn-k.net
Public contact
Name of contact person
| 1st name | matsuura |
| Middle name | |
| Last name | mastuura |
Organization
Nojima Hospital
Division name
ophthalmology
Zip code
682-0863
Address
2714-1 sesakimachi kurayosi
TEL
+81858286676
Homepage URL
matsu224@ncn-k.net
Sponsor or person
Institute
nojima hospital, ophthalmology, Kazuki Matsuura
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Tottoti University
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
Nojima Hospital
Address
2714-1 sesakimachi kurayoshi
Tel
0858226231
mastu224@ncn-k.net
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
| 2023 | Year | 04 | 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
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057876
