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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025180
Receipt No. R000028949
Scientific Title Effect of nasolacrimal duct intubation in patients with nasolacrimal duct obstruction on quality of life and vision
Date of disclosure of the study information 2016/12/08
Last modified on 2016/12/07

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Basic information
Public title Effect of nasolacrimal duct intubation in patients with nasolacrimal duct obstruction on quality of life and vision
Acronym Effect of nasolacrimal duct intubation on quality of life and vision
Scientific Title Effect of nasolacrimal duct intubation in patients with nasolacrimal duct obstruction on quality of life and vision
Scientific Title:Acronym Effect of nasolacrimal duct intubation on quality of life and vision
Region
Japan

Condition
Condition nasolacrimal duct obstruction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the outcomes of the quality of life and visual function after nasolacrimal duct intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1, Assessment of visual function using the functional visual acuity measurement system
2, Evaluation of scored subjective symptom about nasolacrimal duct obstruction
3, Evaluation of quality of life using Glasgow Benefit Inventory
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 patients with lacrimal duct obstruction who were treated with nasolacrimal duct intubation
Key exclusion criteria Subjects were excluded if they had any other ocular or systemic disorders or had undergone any ocular surgery or contact lens use that would create an ocular surface problem or dry eye
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Shiraishi
Organization Ehime University
Division name Ophthalmology
Zip code
Address Shitsukawa, Toon-city, Ehime
TEL 089-960-5361
Email shiraia@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Kamao
Organization Ehime University
Division name Ophthalmology
Zip code
Address Shitsukawa, Toon-city, Ehime
TEL 089-960-5361
Homepage URL
Email t-kamao@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization None
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 愛媛大学医学部附属病院(愛媛県) Ehime University Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 case series
All nasolacrimal duct obstruction patients treated with nasolacrimal duct intubation were examined who meet the selection criteria at Ehime University Hospital from December 2010 to 2016.
Assessment of visual function using the functional visual acuity measurement system
Evaluation of scored subjective symptom about nasolacrimal duct obstruction and Glasgow Benefit Inventory

Management information
Registered date
2016 Year 12 Month 07 Day
Last modified on
2016 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028949

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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