UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024524 |
|---|---|
| Receipt number | R000028229 |
| Scientific Title | Morphological changes in meibomian glands after correction of involutional lower eyelid entropion |
| Date of disclosure of the study information | 2016/10/24 |
| Last modified on | 2024/06/20 17:05:35 |
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Basic information
Public title
Morphological changes in meibomian glands after correction of involutional lower eyelid entropion
Acronym
Changes in meibomian glands after entropion correction.
Scientific Title
Morphological changes in meibomian glands after correction of involutional lower eyelid entropion
Scientific Title:Acronym
Changes in meibomian glands after entropion correction.
Region
| Japan |
Condition
Condition
Involutional lower eyelid entropion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine morphological changes in meibomian glands after correction of involutional lower eyelid entropion.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We asked ocular symptoms using the DEQS questionnaire and performed slit-lamp examination and meibography before and 6 months after surgery.
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
| Device,equipment |
Interventions/Control_1
We performed the undermentioned examinations before and 6 months after correction of involutional lower eyelid entropion.
1) DEQS questionnaire
2) Slit-lamp examination
3) Meibography
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged > 50 years
2) Patients with involutional lower eyelid entropion
3) Patients with approval of participation of the study
Key exclusion criteria
1) Patients aged < 50 years
2) Patients with lower eyelid entropion caused by other etiology (congenital, cicatricial, spastic, etc.)
3) Patients without approval of participation of the study
4) Patients who are judged as being inappropriate for participating the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi Medical University Hospital
Division name
Department of Oculoplastic, Orbital and Lacrimal Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
yasuhiro_tak@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi Medical University Hospital
Division name
Department of Oculoplastic, Orbital and Lacrimal Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
yasuhiro_tak@yahoo.co.jp
Sponsor or person
Institute
Aichi Medical University Hospital
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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-62-3311
aichi-med@esct.bvits.com
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
| 2016 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10792-020-01305-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10792-020-01305-8
Number of participants that the trial has enrolled
8
Results
Irregular eyelid margin, vascular engorgement, and plugged meibomian gland orifices improved only in 1 eyelid of 1 patient postoperatively. The scores of Marx line, meibum expression, and loss of meibomian glands did not statistically change after surgery. The D score was statistically improved after surgery, although the difference between the pre- and postoperative A score was not statistically significant. Tear breakup time did not change after surgery).
Results date posted
| 2024 | Year | 06 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with involutional entropion who underwent posterior layer advancement of the lower eyelid retractors and either a lateral tarsal strip or transcanthal canthopexy procedure.
Participant flow
Informed consent was obtained before surgery.
Adverse events
None.
Outcome measures
The following features were examined for evaluation of meibomian gland dysfunction and dry eye: the presence or absence of eyelid abnormalities (irregular eyelid margin, vascular engorgement, and plugged meibomian gland orifices), Marx line score, meibum expression score, loss of the meibomian glands, A (area) and D (density) scores for corneal fluorescein staining, and tear breakup time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028229
