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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049362


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name