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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017723
Receipt No. R000020529
Scientific Title Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye
Date of disclosure of the study information 2015/07/01
Last modified on 2020/07/15

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Basic information
Public title Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye
Acronym Safety and Efficacy of Excision of Horizontal Canaliculus
Scientific Title Safety and Efficacy of Excision of Horizontal Canaliculus in Severe Aqueous Deficient Dry Eye
Scientific Title:Acronym Safety and Efficacy of Excision of Horizontal Canaliculus
Region
Japan

Condition
Condition aqueous deficient type of dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of horizontal canalicular excision for severe aqueous deficient type of dry eyes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra- and post-operative complications of horizontal canalicular excision
occlusion rate of horizontal canalicular excision
change in tear meniscus height
improvement of ocular surface epithelial damage
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 once horizontal canalicular excision
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
99 years-old >=
Gender Male and Female
Key inclusion criteria 1. both of in- and out-patients
2. over 20 years old at the entry
3. dry eye patients diagnosed using the 2006-version criteria of dry eye
4. primary and secondary dry eyes
5. patients who had the history failed punctal occlusion using either punctal plug or surgical procedure
Key exclusion criteria 1. patients having active ocular disease other than dry eyes
2. patients having the problem of general condition
3. patients who are decided to inappropriate as subjects
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Seika
Middle name
Last name Den
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code 2728513
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL 047-322-0151
Email dens@tdc.ac.jp

Public contact
Name of contact person
1st name Seika
Middle name
Last name Den
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code 2728513
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL 047-322-0151
Homepage URL
Email dens@tdc.ac.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization none
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 Tokyo Dental College
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
Tel 0473220151
Email dens@tdc.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

Other administrative information
Date of disclosure of the study information
2015 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 13
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 Main results already published
Date of protocol fixation
2015 Year 05 Month 07 Day
Date of IRB
2015 Year 05 Month 11 Day
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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