UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054685 |
|---|---|
| Receipt number | R000060994 |
| Scientific Title | A Multi-Institutional Prospective Cohort Study of Surgical Treatment of Acquired Lacrimal Duct Obstruction |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/06/14 13:15:02 |
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Basic information
Public title
A Multi-Institutional Prospective Cohort Study of Surgical Treatment of Acquired Lacrimal Duct Obstruction
Acronym
A Multi-Institutional Prospective Study of Surgery for Acquired Lacrimal Duct Obstruction
Scientific Title
A Multi-Institutional Prospective Cohort Study of Surgical Treatment of Acquired Lacrimal Duct Obstruction
Scientific Title:Acronym
A Multi-Institutional Prospective Study of Surgery for Acquired Lacrimal Duct Obstruction
Region
| Japan |
Condition
Condition
Acquired lacrimal duct obstruction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acquired lacrimal duct obstruction and stenosis (referred to as lacrimal duct obstruction (LDO)) are broadly classified into lacrimal puncture and lacrimal canalicular obstruction and stenosis (referred to as lacrimal puncture and lacrimal canalicular obstruction) and lacrimal sac and nasolacrimal duct obstruction and stenosis (referred to as nasolacrimal duct obstruction). Lacrimal canalicular obstruction can almost always be treated by lacrimal duct recanalization, which uses a lacrimal endoscope to open the obstructed lacrimal duct. On the other hand, the gold standard surgical treatment for nasolacrimal duct obstruction is dacryocystorhinostomy (DCR), in which resection of the maxillary bone or lacrimal bone between the lacrimal sac and nasal cavity, and the lacrimal sac and nasal mucosa are anastomosed. In Japan, however, with the development of nunchaku-type silicone tubes and lacrimal endoscopes, lacrimal duct recanalization for LDO has become more familiar with improved outcomes. In the recent trend toward minimally invasive treatment, lacrimal duct recanalization, which does not require skin or mucosa excision or bone removal, has yet to become popular overseas, even though it is a treatment that meets this need. This is due to various factors such as anatomical structure, treatment outcome, medical insurance system, and healthcare delivery system. Still, it is also thought to be related to the need for more research results showing high evidence. The purpose of this study was to estimate the treatment outcome of endoscopic lacrimal duct recanalization (ELDR) with a certain degree of accuracy by using medical records of examination and treatment of a certain standard prospectively at multiple institutions instead of treatment outcomes reported by a single institution based on the current ununified research subjects and methods. This data will be necessary for future studies comparing the outcomes of ELDR and DCR to determine non-inferiority.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Anatomical and functional success rates for ELDR and DCR
Key secondary outcomes
1 Comparison of surgical success rates by obstruction site
2 Percentage of each treatment selection
3 Patient satisfaction
4 Impact on QOL
5 Comparison of surgical invasiveness
6 Hospitalization period
7 Quantitative evaluation of pre-and postoperative changes in tear fluid volume
8 Ratio of intraoperative and postoperative complications
9 Prevalence of lacrimal drainage system concretions
10 Rate of spontaneous healing in the absence of surgical treatment
11 Adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with acquired lacrimal duct obstruction, with symptoms associated with lacrimal duct obstruction such as epiphora, discharge, and blurred vision, and who are willing to undergo surgical treatment. Patients who do not wish to undergo surgical treatment but who give their consent to participate in this study.
2. Patients at least 18 years old and with written consent to participate in this study have been obtained.
Key exclusion criteria
1. Patients with stenosis of the lacrimal punctum alone
2. Patients with endoscopic lacrimal duct intubation to prevent lacrimal duct obstruction caused by anticancer drugs
3. Patients with lacrimal duct obstruction caused by the tumor
4. Patients whose tear flow symptoms are thought to be caused by secretory tear flow, such as eyelid disease or keratoconjunctival disease, or by conductive tear flow other than lacrimal duct obstruction, or who are difficult to distinguish from other types of tear flow
5. Patients with congenital malformation syndrome, developmental delay, or congenital facial dysplasia
6. Other patients who are deemed by the physician in charge to be difficult to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kamao |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Ophthalmology & Regenerative Medicine
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime
TEL
089-960-5361
t-kamao@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kamao |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Ophthalmology & Regenerative Medicine
Zip code
791-0295
Address
454 Shitsukawa, Toon, 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
nstitutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, 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）、筑波大学附属病院（茨城県）、兵庫県立尼崎総合医療センター（兵庫県）、多根記念眼科病院（大阪府）、鶴丸眼科（福岡県）、聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
Method of recruitment: all patients who visited the participating facilities in 2024-2025 and met the selection criteria.
Measurements: patient background, interview, quality of life assessment, visual examination, slit-lamp microscopy, anterior segment OCT, palpation, Schirmer test, lacrimal irrigation test, CT, MRI, lacrimal and nasal endoscopy, surgical records, adverse events
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060994
