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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028308
Receipt No. R000032390
Scientific Title The efficacy of contribution by nurse on dry eye patient education
Date of disclosure of the study information 2017/07/20
Last modified on 2019/01/20

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Basic information
Public title The efficacy of contribution by nurse on dry eye patient education
Acronym Contribution by nurse on patient education
Scientific Title The efficacy of contribution by nurse on dry eye patient education
Scientific Title:Acronym Contribution by nurse on patient education
Region
Japan

Condition
Condition Meibomian gland dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the additional instruction by nurses contribute to the treatment result or not
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective symptoms
Lid margin, tearfilm break up time, tear fluid volume
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 additional instruction in patients education
Interventions/Control_2 warming around eyelids
Twice a day, for one month
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
95 years-old >=
Gender Male and Female
Key inclusion criteria 1) MGD patients who visit Ohshima Eye Hospital from the approval by IRB through March 2021
2) agreed to be enrolled into this clinical study after explanation of this clinical study
Key exclusion criteria 1) patients who cannot understand the meaning of this clinical study
2) patients who is determined not to be adequate to join this clinical study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Morishige
Organization Ohshima Eye Hospital
Division name Ophthalmology
Zip code
Address 11-8 Kamigofukumachi, Hakataku, Fukuoka
TEL 092-281-3020
Email morishig@corneajp.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Morishige
Organization Ohshima Eye Hospital
Division name Ophthalmology
Zip code
Address 11-8 Kamigofukumachi, Hakata-ku, Fukuoka
TEL 092-281-3020
Homepage URL
Email morishig@corneajp.com

Sponsor
Institute Ohshima Eye Hospital
Institute
Department

Funding Source
Organization Ohshima Eye Hospital
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
Address
Tel
Email

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
2017 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2019 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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