UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052493 |
|---|---|
| Receipt number | R000059903 |
| Scientific Title | Changes in Lipid Layer and Tear Film Dynamics during Intense Pulsed Light Treatment of Patients with Meibomian Gland Dysfunction |
| Date of disclosure of the study information | 2023/10/14 |
| Last modified on | 2023/10/13 17:28:33 |
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Basic information
Public title
Changes in Lipid Layer and Tear Film Dynamics during Intense Pulsed Light Treatment of Patients with Meibomian Gland Dysfunction
Acronym
Changes in Lipid Layer and Tear Film Dynamics during Intense Pulsed Light Treatment of Patients with Meibomian Gland Dysfunction
Scientific Title
Changes in Lipid Layer and Tear Film Dynamics during Intense Pulsed Light Treatment of Patients with Meibomian Gland Dysfunction
Scientific Title:Acronym
Changes in Lipid Layer and Tear Film Dynamics during Intense Pulsed Light Treatment of Patients with Meibomian Gland Dysfunction
Region
| Japan |
Condition
Condition
Meibomian Gland Dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure and examine indices of tear film dynamics (NIBUT: Non Invasive Break Up Time, TMH: Tear Meniscus Height) and lipid layer dynamics (LLT: Lipid Layer Thickness) before and after IPL using Idra
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LLT:Lipid Layer Thickness
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who underwent one course of IPL (four courses in total) between November 1, 2020 and September 20, 2023 at Chukyo Eye Clinic
(2) Patients who are 20 years old or older
Key exclusion criteria
(1) Pregnant or lactating women, or patients with a photosensitivity, history of keloids or epileptic seizures
(2) Patients with unreliable biometric data from pre- and postoperative examinations
(3) Cases that the principal investigator determines to be unsuitable
(4) Cases in which unforeseen circumstances occurred during the procedure and the IPL procedure deviated from the standard IPL procedure (Toyos protocol, 4 sessions per course, DE(MGD)mode, 590nm Filter)
Target sample size
120
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
456-0032
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
| 2023 | Year | 10 | Month | 14 | 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
80
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
| 2023 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
