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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032840
Receipt No. R000034165
Scientific Title Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center randomized controlled trial
Date of disclosure of the study information 2018/06/01
Last modified on 2019/10/19

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Basic information
Public title Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center randomized controlled trial
Acronym Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center RCT
Scientific Title Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center randomized controlled trial
Scientific Title:Acronym Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center RCT
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effectiveness and safety of the Lacrimal sac massage for congenital nasolacrimal duct obstruction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cure rate at 1 month
Key secondary outcomes Duration of treatment until cure (up to 3 month), Number of lacrimal sac massage until cure, drop-out rate, rate of surgical intervention, and safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Lacrimal sac massage twice a day (10 times each) by trained family with antibiotic eye drops three times a day
Interventions/Control_2 Antibiotic eye drops three times a day
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
3 months-old <=
Age-upper limit
12 months-old >
Gender Male and Female
Key inclusion criteria (1) Patients from three months to twelve months who are diagnosed with congenital nasolacrimal duct obstruction.
(2) Patients whose legally acceptable representative provided voluntary written consent for participation in this study
Key exclusion criteria 1. Patients with congenital malformation, mental retardation, and facial anomalies.
2. Patients who have had a history of perinatal abnormality.
3. Patients with diseases such as keratitis and epiblepharon that may lead epiphora and eye discharge.
4. Patients who have had a history of surgery on lacrimal apparatus.
5. Patients who have had a history of facial injury that may affect lacrimal duct.
6.Patients who have had a history of infectious disease such as epidemic keratoconjunctivitis and herpes palpebrae that may lead lacrimal duct abnormality.
7. Patients with atresia puncti lacrimalis or lacrimal fistula.
8.Patients with congenital dacryocystocele or acute dacryocystitis.
9. Patients with severe blepharitis.
10. Patients who are considered inadequate to participate in this study by the medical doctor.
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Takeuchi
Organization Yokohama City University
Division name Ophthalmology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2683
Email takeuchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Takeuchi
Organization Yokohama City University
Division name Ophthalmology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2683
Homepage URL
Email takeuchi@yokohama-cu.ac.jp

Sponsor
Institute Department of Ophthalmology, Yokohama City University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa Children's Medical Center
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
2018 Year 06 Month 01 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
2018 Year 05 Month 18 Day
Date of IRB
2018 Year 05 Month 14 Day
Anticipated trial start date
2018 Year 06 Month 04 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2019 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034165

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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