UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022747 |
|---|---|
| Receipt number | R000026209 |
| Scientific Title | The safety and efficaly of Intensed Pulse Light in patients with meibomian gland dysfunction |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2024/05/12 22:23:48 |
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Basic information
Public title
The safety and efficaly of Intensed Pulse Light in patients with meibomian gland dysfunction
Acronym
The safety and efficaly of IPLin MGD
Scientific Title
The safety and efficaly of Intensed Pulse Light in patients with meibomian gland dysfunction
Scientific Title:Acronym
The safety and efficaly of IPLin MGD
Region
| Japan |
Condition
Condition
Meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety and efficafy of IPL in MGD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
meibum quality grading
Key secondary outcomes
Symptoms, Lipid layer thickness, BUT, meiboscore, Schirmer test, meniscus height, NIBUT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
IPL treatment
4 times for each 3 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
meibomian gland dysfunction
Key exclusion criteria
Other ocular diseases, the history of ocular surgery within 3 months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minuma-Ku, Saitama,
TEL
0486865588
Homepage URL
http://www.itoh-clinic.com/
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Itoh Clinic
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama, Japan
Tel
0486865588
ritoh@za2.so-net.ne.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
伊藤医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Suspended
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026209
