UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050757 |
|---|---|
| Receipt number | R000056525 |
| Scientific Title | A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction. |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2025/03/30 15:10:37 |
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Basic information
Public title
A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction.
Acronym
A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction.
Scientific Title
A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction.
Scientific Title:Acronym
A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction.
Region
| Japan |
Condition
Condition
congenital nasolacrimal duct obstruction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the use of dacryoendoscopy improves the success rate of initial surgical probing in pediatric patients with unilateral congenital nasolacrimal duct obstruction compared to blind probing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of cure rates
At 21-35 days postoperatively, the percentage of cases that are "cured" according to the "Criteria for Cure" is compared between the two groups. The cure rate is defined as (the number of cured cases)/(the number of cases in the Full Analysis Set).
Comparison of improvement rates
If there is a significant difference in the cure rate, the ratio of "improved, which is the sum of "cured" and "mildly improved, is compared between the two groups as a fixed-order test. The rate of improvement is defined as (the number of cases in which the criteria were "cured" and "improved")/(the number of cases in the Full Analysis Set).
Analysis of the Primary Endpoints:
For primary endpoint 1 (cure rate), a logistic regression analysis will be conducted using the allocation adjustment factor (age in months) as a covariate. The point estimate and 95% confidence interval of the odds ratio for cure in the endoscopy group relative to the bougie group will be calculated. A two-sided hypothesis test at a 5% significance level will be performed to assess whether the odds ratio is equal to 1. The hypothesis test for primary endpoint 2 will only be performed if this test yields statistically significant results.
For primary endpoint 2 (improvement rate), a logistic regression analysis will likewise be conducted using the allocation adjustment factor (age in months) as a covariate. The point estimate and 95% confidence interval of the odds ratio for improvement in the endoscopy group relative to the bougie group will be calculated, and a two-sided hypothesis test at a 5% significance level will be conducted to evaluate whether the odds ratio is equal to 1.
Key secondary outcomes
Comparison of patient satisfaction: A satisfaction questionnaire is administered at the one-month postoperative visit. Satisfaction is rated on a 3-point scale of "satisfactory, normal, and unsatisfactory".
Prevalence of dacryolith: The percentage (%) of dacryolith (stones in the lacrimal duct) confirmed in the lacrimal duct endoscopy group will be investigated.
Safety endpoints: adverse events.
Analysis of the Secondary Endpoints:
For secondary endpoint 3, patient satisfaction, the proportion of patients who responded as "satisfied" will be compared between the two groups using Fisher's exact test. The significance level will be set at 5%.
For secondary endpoint 4, the prevalence of dacryoliths (tear stones), the percentage will be calculated and evaluated descriptively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
blind probing group
Perform surgery under local anesthesia. Either a bougie or a cannula is used as a probe to puncture the obstructed site by blind manipulation. After puncturing, the passage of water into the nasopharynx is checked (either visually or by swallowing). The site of obstruction, the feeling during perforation, and whether or not the passage of water was confirmed after the procedure should be noted in the operative record.
Interventions/Control_2
dacryoendoscopy group
Perform surgery under local anesthesia. A vent-type dacryoendoscopy is used as a probe. No matter the difference in manufacturer, tip diameter, or pixel count. The obstructed site is confirmed under visualization and punctured. After punctured, the passage of water reaches the nasopharynx is confirmed (either visually or by swallowing). The findings of the obstruction site and the feeling during puncture, other dacryoendoscopic findings such as dacryolith, and whether the passage of water is confirmed postoperatively should be documented in the operation record.
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
| 6 | months-old | <= |
Age-upper limit
| 16 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with unilateral congenital nasolacrimal duct obstruction, accompanied by symptoms of epiphora or mucoid discharge, and whose surrogate (guardian) is willing to undergo initial surgical treatment.
2. Patients between the ages of 6 and 16 months whose surrogate (guardian) provides written consent for participation in this study.
Key exclusion criteria
1. patients with congenital malformation syndrome, developmental delay, facial deformity, or facial abnormality
2. patients with perinatal abnormalities such as prematurity and low birth weight
3. patients with other diseases such as keratitis, which cause epiphora and mucoid discharge and are difficult to distinguish
4. patients with a history of surgery related to the lacrimal apparatus
5. patients with a history of previous trauma to the eyelid or face that may cause damage to the lacrimal duct
6. patients with a history of infection such as epidemic keratoconjunctivitis or eyelid herpes, which may cause abnormalities of the lacrimal duct
7. patients with lacrimal punctum obstruction or lacrimal fistula
8. patients with congenital dacryocele or acute dacryocystitis
9. other patients whom the physician in charge determines to be difficult to participate in the study
Target sample size
408
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Shiraishi |
Organization
Ehime University Hospital
Division name
Department of Ophthalmology
Zip code
791-0295
Address
454 Shizu, Toon City, Ehime, Japan
TEL
+8189-964-5111
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Matsumura |
Organization
Kanagawa Children's Medical Center
Division name
Department of Ophthalmology
Zip code
232-8555
Address
2-138-4 Mutsugawa, Minami-ku, Yokohama City, Kanagawa, Japan
TEL
+8145-711-2351
Homepage URL
kcmceyecare@gmail.com
Sponsor or person
Institute
Japanese Society of Lacrimal Passage and Tear Dynamics
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Lacrimal Passage and Tear Dynamics
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
Kanagawa Children's Medical Center
Address
2-138-4 Mutsugawa, Minami-ku, Yokohama City, Japan
Tel
+8145-711-2351
mail1/Email1 rin-shinsei.1591@kanagawa-pho.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
神奈川県立こども医療センター（神奈川県）、真生会富山病院（富山県）、兵庫県立尼崎総合医療センター（兵庫県）、大阪赤十字病院（大阪府）、徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056525
