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 2023/10/27 10:35:28

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2016 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 24 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 10 Month 21 Day

Last modified on

2023 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028229


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name