UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of surgical outcome after endoscopic dacryocystorhinostomy
Acronym	Surgical outcome of endoscopic DCR
Scientific Title	Evaluation of surgical outcome after endoscopic dacryocystorhinostomy
Scientific Title:Acronym	Surgical outcome of endoscopic DCR
Region	Japan

Condition
Condition	nasolacrimal duct obstruction,dacryocystitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate outcomes and prognostic factors of endoscopic DCR perfomed at Japanese Red Cross Osaka Hosopital and Hyogo Prefectural Amagasaki General Medical Center.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Anatomic patency based on lacrimal irrigation before surgery, 7 weeks after surgery, and 52 weeks after surgery.
Key secondary outcomes	1.Assessment of change in tear meniscus height measured by anterior segment optical coherence tomography. 2.Quantitative assessment of improvement in subjective symptoms scored by tree-grade evaluation as follows: (1)complete resolution,(2)moderate epiphora,(3)no improvement These evaluations were performed before surgery, 7 weeks after surgery, and 52 weeks 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	1.The cases of nasolacrimal duct obstruction,acute and chronic dacryocystitis. 2.The case that have never undergone prior external and/or endoscopic DCR.
Key exclusion criteria	1.The case in which the part of obstruction is proximal to common canaliculus. 2.The case undergone endoscopic sinus surgery at the same time of endoscopic DCR. 3.The case of which consent can't be obtained from the patients.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Matsuyama
Organization	Japanese Red Cross Osaka Hosopital
Division name	Ophthalmology
Zip code	543-8555
Address	5-30 Fudegasakicho, Tennoji-ku,Osaka
TEL	0667745111
Email	hospital@osaka-med.jrc.or.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Matsuyama
Organization	Japanese Red Cross Osaka Hosopital
Division name	Ophthalmology
Zip code	543-8555
Address	5-30 Fudegasakicho, Tennoji-ku,Osaka
TEL	0667745111
Homepage URL	https://www.osaka-med.jrc.or.jp/aboutus/information/ethics.html
Email	hospital@osaka-med.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Osaka Hosopital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hyougo Prefectural Amagasaki General Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Osaka Hosopital
Address	5-30 Fudegasakicho, Tennoji-ku,Osaka
Tel	0667745111
Email	hospital@osaka-med.jrc.or.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	大阪赤十字病院、兵庫県立尼崎総合医療センター

Other administrative information
Date of disclosure of the study information	2021 Year 05 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	2018 Year 04 Month 01 Day
Date of IRB	2020 Year 09 Month 04 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 02 Month 09 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047951