UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038047
Receipt number R000043369
Scientific Title Postoperative changes in upper eyelid position after subbrow or pinch blepharoplasty for correction of dermatochalasis
Date of disclosure of the study information 2019/09/19
Last modified on 2019/09/18 21:26:41

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Basic information

Public title

Postoperative changes in upper eyelid position after subbrow or pinch blepharoplasty for correction of dermatochalasis

Acronym

Upper eyelid position changes after blepharoplasty

Scientific Title

Postoperative changes in upper eyelid position after subbrow or pinch blepharoplasty for correction of dermatochalasis

Scientific Title:Acronym

Upper eyelid position changes after blepharoplasty

Region

Japan


Condition

Condition

Dermatochalasis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure upper eyelid position changes after subbrow or pinch blepharoplasty and to compare the results between the surgical procedures.

Basic objectives2

Others

Basic objectives -Others

Hypothesis corroboration

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Upper eyelid position changes after subbrow or pinch blepharoplasty

Key secondary outcomes

The difference in the results between the surgical procedures.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Pinch blepharoplasty

Interventions/Control_2

Subbrow blepharoplasty

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who do not have history of eyelid surgery or that of other eyelid diseases, and those who can be follow-up for 3 months.

Key exclusion criteria

None.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Takahashi

Organization

Aichi Medical University Hospital

Division name

Oculoplastic, Orbital & 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 Rika
Middle name
Last name Watanabe

Organization

Aichi Medical University Hospital

Division name

Hospital Management Section

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

TEL

0561-62-3311

Homepage URL


Email

amu_ethics@aichi-med-u.ac.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 Hospital

Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

Tel

0561-62-3311

Email

amu_ethics@aichi-med-u.ac.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

愛知医科大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 19 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

2019 Year 06 Month 18 Day

Date of IRB

2019 Year 09 Month 10 Day

Anticipated trial start date

2019 Year 09 Month 19 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 18 Day

Last modified on

2019 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name