UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057501 |
|---|---|
| Receipt number | R000065677 |
| Scientific Title | Age-related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2025/04/03 17:09:18 |
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Basic information
Public title
Age-related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients
Acronym
Age-related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients
Scientific Title
Age-related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients
Scientific Title:Acronym
Age-related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients
Region
| Japan |
Condition
Condition
Meibomian Gland Dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Age-Related Differences in the Efficacy of Intense Pulsed Light Therapy for Meibomian Gland Dysfunction in Female Patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid Layer Thickness
Key secondary outcomes
Uncorrected and Best-Corrected Visual Acuity
Superficial Punctate Keratopathy (SPK) Score
Fluorescein Break-Up Time (FBUT)
Non-Invasive Break-Up Time (NIBUT)
Tear Meniscus Height (TMH)
Meibomian Gland Grade Score
Meibum Characteristics (Quality and Expressibility)
Patient Satisfaction (SPEED Score and Visual Analog Scale [VAS])
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
| 95 | years-old | > |
Gender
Female
Key inclusion criteria
A total of 80 female patients who underwent one course of IPL therapy (four sessions with 2- to 4-week intervals) at Chukyo Eye Clinic between April 1, 2023, and December 31, 2024, were included in the study. The patients were divided into two age groups: under 50 years (n = 40) and 50 years or older (n = 40).
Female
Aged 20 years or older
Key exclusion criteria
Patients who were pregnant or breastfeeding, had photosensitivity, a history of keloid formation, or a history of epileptic seizures
Patients whose biometric data obtained before or after treatment were deemed unreliable
Patients judged to be unsuitable for inclusion by the principal investigator
Patients in whom unexpected events occurred during the procedure, resulting in deviation from the standard IPL treatment protocol (Toyos protocol: four sessions per course, DE (MGD) mode, 590 nm filter)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | gotoda |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
4560032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
TEL
0528831543
sgotoda@chukyo-eyeclinic.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | gotoda |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
TEL
0528831543
Homepage URL
sgotoda@chukyo-eyeclinic.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Eye Clinic Ethics Review Committee
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya City, Aichi Prefecture
Tel
0528831543
snimi@chukyomedical.co.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 | 04 | Month | 03 | 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
68
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2028 | Year | 04 | 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
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065677
