UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043263 |
|---|---|
| Receipt number | R000049362 |
| Scientific Title | The effect of the application of ophthalmic ointment for protection against dry eyes during pediatric strabismus surgeries |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2021/02/05 21:07:36 |
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Basic information
Public title
The effect of the application of ophthalmic ointment for protection against dry eyes during pediatric strabismus surgeries
Acronym
The effect of the application of ophthalmic ointment for protection against dry eyes during pediatric strabismus surgeries
Scientific Title
The effect of the application of ophthalmic ointment for protection against dry eyes during pediatric strabismus surgeries
Scientific Title:Acronym
The effect of the application of ophthalmic ointment for protection against dry eyes during pediatric strabismus surgeries
Region
| Japan |
Condition
Condition
strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of the application of ophthalmic ointment for protection against dry eyes after strabismus surgeries
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measured the pain scale with using face scale at immediately after the surgery, 3hours later, 6hours later, at dinner and discharge.
We assessed the number of times of taking pain killers, feeling nausea and vomiting until discharge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At the start of surgery, ophthalmic ointment was used for protection against dry eyes.
Interventions/Control_2
At the start of surgery, ophthalmic ointment was not used for protection against dry eyes.
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study group included the patients who were scheduled for unilateral/ bilateral strabismus surgery. Ages ranged from 5 years old to 15 years old.
Key exclusion criteria
The patients has allergy to local anesthesia.
The patients have mental retardation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Okamoto |
Organization
Kitasato university hospital
Division name
Department of Anesthesiology
Zip code
252-0329
Address
1-15-1 kitasato minami ward sagamihara, Kanagawa, Japan
TEL
042-778-8111
okasuke@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Ei |
| Middle name | |
| Last name | Ito |
Organization
Kitasato University Hospital
Division name
Department of Anesthesiology
Zip code
252-0329
Address
1-15-1 kitasato minami ward sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
eiitoh61@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
Kitasato University
Address
1-15-1 kitasato minami ward sagamihara, Kanagawa, Japan
Tel
042-778-8111
eiitoh61@gmail.com
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
| 2021 | Year | 02 | Month | 05 | 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
50
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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049362
