UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011112 |
|---|---|
| Receipt number | R000013016 |
| Scientific Title | Tear osmolality before and after cataract surgery |
| Date of disclosure of the study information | 2013/07/04 |
| Last modified on | 2024/01/11 17:22:13 |
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Basic information
Public title
Tear osmolality before and after cataract surgery
Acronym
Tear osmolality and cataract surgery
Scientific Title
Tear osmolality before and after cataract surgery
Scientific Title:Acronym
Tear osmolality and cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tear osmolality before and after cataract surgery
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tear osmolality
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Tear osmolality
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 aged 20 and over (sex unquestioned)
2) Patients received cataract surgery
3) Patients who provided written informed consent for participating in this study.
Key exclusion criteria
1) Patients who are considered to be inapproriate by the investigators.
2) Patients with drug allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TSUTOMU |
| Middle name | |
| Last name | IGARASHI |
Organization
Nippon Medical School
Division name
Ophthalmology
Zip code
1138602
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
tutomu@nms.ac.jp
Public contact
Name of contact person
| 1st name | TOMONAGA |
| Middle name | |
| Last name | Takase |
Organization
Nippon Medical School
Division name
Ophthalmology
Zip code
1138602
Address
1-1-5 Sendagi, Bunkyoku, Tokyo
TEL
03-3822-2131
Homepage URL
clinicaltrial@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
MHLW
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
Nippon Medical School Hospital
Address
1-1-5, Sendagi, Bunkyoku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.ac.jp
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
| 2013 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jnms/88/3/88_JNMS.2021_88-405/_pdf/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jnms/88/3/88_JNMS.2021_88-405/_pdf/-char/en
Number of participants that the trial has enrolled
39
Results
Results
Results date posted
| 2024 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
39 patients (19 male, 20 female patients)
Participant flow
outpatient
Adverse events
nothing
Outcome measures
Schirmer test, BUT, Staining score, Tosm, corneal sensitivity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013016
