UMIN-CTR Clinical Trial

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
Email	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
Email	eiitoh61@gmail.com

Sponsor
Institute	Kitasato University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049362