UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039222
Receipt number R000044731
Scientific Title Preoperative evaluation for vitreous gel by using ultrasound elastography
Date of disclosure of the study information 2020/01/22
Last modified on 2021/07/28 12:57:58

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Basic information

Public title

Preoperative evaluation for vitreous gel by using ultrasound elastography

Acronym

Preoperative evaluation for vitreous gel by using ultrasound elastography

Scientific Title

Preoperative evaluation for vitreous gel by using ultrasound elastography

Scientific Title:Acronym

Preoperative evaluation for vitreous gel by using ultrasound elastography

Region

Japan


Condition

Condition

Vitreoretinal diseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims at the evaluation for the structure and elasticity of bursa premacularis and martegiani's area by using ultrasound elastography in the patients with vitreoretinal diseases before vitreous surgery.

Basic objectives2

Others

Basic objectives -Others

To perform the vitreous surgery smoothly by grasping the preoperative pathophysiology of vitreoretinal diseases.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To draw the structure of eye ball by using ultrasound elastography (Ultrasound Aplio i700TM, Canon Medical Systems) in the patients before vitreous 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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

To draw the structure of eye ball by using ultrasound elastography.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients more than 40 years old who are subjected to vitreous surgery for vitreoretinal diseases.

Key exclusion criteria

The patients who had the past history of intraocular surgery are excluded.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tsunehiko
Middle name
Last name Ikeda

Organization

Osaka Medical College

Division name

Department of Ophthalmology

Zip code

569-8686

Address

2-7 Daigaku-machi Takatsuki-City

TEL

072-683-1221

Email

tikeda@osaka-med.ac.jp


Public contact

Name of contact person

1st name Tsunehiko
Middle name
Last name Ikeda

Organization

Osaka Medical College

Division name

Department of Ophthalmology

Zip code

569-8686

Address

2-7 Daigaku-machi Takatsuki-City

TEL

072-683-1221

Homepage URL


Email

tikeda@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

None

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

The Ethics Committee of Osaka Medical College

Address

2-7 Daigaku-machi Takatsuki-City, Osaka

Tel

072-683-1221

Email

rinri@art.osaka-med.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

大阪医科大学(大阪府)


Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 22 Day


Related information

URL releasing protocol

Preoperative evaluation of the vitreous body using ultrasound elastography

Publication of results

Partially published


Result

URL related to results and publications

Preoperative evaluation of the vitreous body using ultrasound elastography

Number of participants that the trial has enrolled

107

Results

We evaluated the elasticity of the vitreous using preoperative ultrasound elastography
for various vitreoretinal diseases such as
idiopathic epiretinal membrane, idiopathic
macular hole, rhegmatogenous retinal
detachment, and diabetic retinopathy. In
cases with bursa premacularis, the vitreous in front of the macula was found to be high elasticity.

Results date posted

2021 Year 07 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 04 Month 15 Day

Baseline Characteristics

Patients with vitreoretinal diseases that
required vitreoretinal surgery

Participant flow

Preoperative examination

Adverse events

None

Outcome measures

Evaluation of the elasticity of the vitreous body using ultrasound elastography

Plan to share IPD

No specific plans

IPD sharing Plan description

Already reported at the 125th Japanese
Society of Ophthalmology, and plan to write an original paper in the near future.


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 01 Month 07 Day

Date of IRB

2020 Year 03 Month 16 Day

Anticipated trial start date

2020 Year 04 Month 22 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 10 Month 31 Day


Other

Other related information

None


Management information

Registered date

2020 Year 01 Month 22 Day

Last modified on

2021 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044731


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name