UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056984 |
|---|---|
| Receipt number | R000065119 |
| Scientific Title | Relationship Between the Effectiveness of Intense Pulsed Light Therapy and Examination Findings in Meibomian Gland Dysfunction |
| Date of disclosure of the study information | 2025/02/11 |
| Last modified on | 2025/02/09 14:23:11 |
* 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
Relationship Between the Effectiveness of Intense Pulsed Light Therapy and Examination Findings in Meibomian Gland Dysfunction
Acronym
Relationship Between the Effectiveness of IPL and Examination Findings in MGD
Scientific Title
Relationship Between the Effectiveness of Intense Pulsed Light Therapy and Examination Findings in Meibomian Gland Dysfunction
Scientific Title:Acronym
Relationship Between the Effectiveness of IPL Therapy and Examination Findings in MGD
Region
| Japan |
Condition
Condition
Meibomian Gland Dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intense Pulsed Light (IPL) is effective for meibomian gland dysfunction (MGD). We retrospectively compared tear film and meibomian gland-related parameters before IPL treatment between the effective and ineffective groups.
Basic objectives2
Others
Basic objectives -Others
A study on prognostic factors determining the effectiveness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lid margin findings, meibum grade, meiboscore, morphological features by non-contact meibography
Key secondary outcomes
symptoms, fluorescein tear film breakup time, corneal and conjunctival staining, Schirmer value
Base
Study type
Others,meta-analysis etc
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who did not respond to conventional MGD treatment, underwent IPL therapy, met all examination criteria, and were followed up for more than three months.
Key exclusion criteria
Patients who had an ocular infection or inflammation within the past three months, underwent intraocular surgery within the past six months, or were deemed inappropriate by the principal investigator.
Target sample size
100
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, Minumaku, 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
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Reiko
Funding Source
Organization
Itoh Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itoh Clinic
Address
626-11, Minaminakano, Minuma-ku
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 11 | 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
73
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 02 | Day |
Other
Other related information
Retrospective Study
Management information
Registered date
| 2025 | Year | 02 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065119
