UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025180 |
|---|---|
| Receipt number | 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 | 2023/06/13 10:10:55 |
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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 | Atsushi |
| Middle name | |
| Last name | Shiraishi |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
Shitsukawa, Toon-city, Ehime
TEL
089-960-5361
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kamao |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
Shitsukawa, Toon-city, Ehime
TEL
089-960-5361
Homepage URL
t-kamao@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon-city, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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
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
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/pdf/10.1080/02713683.2020.1760305
Number of participants that the trial has enrolled
91
Results
When the visual functions were compared before and after the treatment, there was no significant difference found in the CDVA in both groups. In the N group, the FVA and VMR were significantly increased, however no significant change was found in both the FVA and VMR in the D group. In the D group, there were significant decreases in the Schirmer I test, BUT, and TMH, however the keratoconjunctival staining score increased significantly.
Results date posted
| 2023 | Year | 06 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
All patients were >20-years-of-age and were diagnosed with unilateral NLDO at the Ehime University Hospital. All of the patients were examined and treated by 3 ophthalmologists (TK, NT, AS). The diagnosis of a NLDO was based on the dye disappearance test, lacrimal irrigation, lacrimal cannula- tion, and dacryoendoscopic examinations. The subjects were treated by a new technique of dacryoendoscopic probing and sheath-guided bicanalicular intubation (SG-BCI), and none had any further treatment for the 6 months after the lacrimal stent removal. The cases that had a recurrence or were pre- scribed additional treatment were excluded.
Participant flow
All patients were treated with dacryoendoscopic probing, and the SG-BCI technique was used as described.5,11 Details of the probing and intubation are shown in Figure 1. This technique enabled surgeons to perform lacrimal passage reconstruction procedures under dacryoendoscopic observations without blind manipulation. After the intubation, all subjects were treated with topical 0.3% gatifloxacin and 0.1% fluorometholone 4 times/day, and a saline nasal lavage was applied regularly until the stent was removed. The stent was removed after 10-12 weeks.
Adverse events
None
Outcome measures
QOL assessment, QOV assessment, dry eye assessment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 12 | Day |
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
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028949
