UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021754 |
|---|---|
| Receipt number | R000025089 |
| Scientific Title | Evaluation of the effect on visual function in patients treated with nasolacrimal intubation using dacryoendoscopy |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2021/10/09 00:17:31 |
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Basic information
Public title
Evaluation of the effect on visual function in patients treated with nasolacrimal intubation using dacryoendoscopy
Acronym
Effect of nasolacrimal intubation on visual function
Scientific Title
Evaluation of the effect on visual function in patients treated with nasolacrimal intubation using dacryoendoscopy
Scientific Title:Acronym
Effect of nasolacrimal intubation on visual function
Region
| Japan |
Condition
Condition
Nasolacrimal duct obstruction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate vision related quality of life, visual function, tear film state before and after nasolacrimal intubation in patients with nasolacrimal duct obstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional visual acuity before and after surgery
Key secondary outcomes
Visual acuity, contrast sensitivity, higher order aberration, tear film stability, vision related quality of life before and after surgery
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with nasolacrimal duct obstruction
Key exclusion criteria
patients who do not cooperate to the examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sujin Hoshi |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Ophthalmology
Zip code
Address
1-1-1 Tennoudai, Tsukuba city, Ibaraki, Japan
TEL
029-853-3148
hoshisujin@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sujin Hoshi |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Ophthalmology
Zip code
Address
1-1-1 Tennoudai, Tsukuba city, Ibaraki, Japan
TEL
029-853-3148
Homepage URL
hoshisujin@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of visual function, tear film state, vision related quality of life in patients with nasolacrimal duct obstruction before and after nasolacrimal intubation will be performed.
Management information
Registered date
| 2016 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025089
