UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032840 |
|---|---|
| Receipt number | 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 | 2024/04/02 21:39:20 |
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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 | Masaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Yokohama City University
Division name
Ophthalmology
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2683
takeuchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Yokohama City University
Division name
Ophthalmology
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872800
Homepage URL
takeuchi@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Yokohama City University
Institute
Department
Personal name
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
Yokohama City Univ. IRB
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0457872800
rinri@yokohama-cu.ac.jp
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
It will be piblished with the research paper.
Publication of results
Unpublished
Result
URL related to results and publications
The results of this study will be published in the research paper being submitted.
Number of participants that the trial has enrolled
102
Results
The results of this study are described in the research paper being submitted.
Results date posted
| 2023 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The results of this study are described in the research paper being submitted.
Participant flow
The results of this study are described in the research paper being submitted.
Adverse events
No adverse event was observed during the study period.
Outcome measures
The primary endpoint was a comparison of the 1-month resolution rate in the massage and non-massage groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 08 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034165
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