UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017723 |
|---|---|
| Receipt number | 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 | 2026/08/29 20:37:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
The Jikei University School of Medicine, Katsushika Medical Center
Division name
Department of Ophthalmology
Zip code
125-8506
Address
6-41-2 Aoto Katsushika Tokyo, Japan
TEL
03-3603-2111
denseika@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Seika |
| Middle name | |
| Last name | Den |
Organization
The Jikei University School of Medicine, Katsushika Medical Center
Division name
Department of Ophthalmology
Zip code
125-8506
Address
6-41-2 Aoto Katsushika Tokyo, Japan
TEL
03-3603-2111
Homepage URL
denseika@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Seika DEN
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
International University of Health and Welfare Ichikawa General Hospital
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
Tel
0473220151
ishii-mutsumi-zh@ihwg.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
東京歯科大学市川総合病院(現国際医療福祉大学市川総合病院 )
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
| 2026 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020529
