UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032952
Receipt number R000037563
Scientific Title Effect of silicone oil extraction surgery on retinal thickness and retinal vascular layer
Date of disclosure of the study information 2018/07/01
Last modified on 2023/06/16 18:12:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of silicone oil extraction surgery
on retinal thickness and retinal vascular layer

Acronym

SO extraction and retinal vessels

Scientific Title

Effect of silicone oil extraction surgery
on retinal thickness and retinal vascular layer

Scientific Title:Acronym

SO extraction and retinal vessels

Region

Japan


Condition

Condition

All retinal diseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the retinal vascular change before and after silicone oil extraction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

changes after silicone oil extraction

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The cases that have silicone oil extraction

Key exclusion criteria

The cases that fundus examinations can not be done due to opacity, e.g. corneal opacity

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Kaneko

Organization

Nagoya University

Division name

Ophthalmology

Zip code

4668550

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

+81-52-744-2277

Email

h-kaneko@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Kaneko

Organization

Nagoya University Hospital

Division name

Ophthalmology

Zip code

4668550

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

+81-52-744-2277

Homepage URL


Email

h-kaneko@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Hospital

Address

65 Tsurumai-cho, Showa-ku, Nagoya

Tel

+81-52-744-2277

Email

ethic@med.nagoya-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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 01 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

0

Results

Terminated because it was found that image quality acceptable for clinical trials could not be obtained immediately after surgery.

Results date posted

2023 Year 06 Month 16 Day

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

Terminated

Date of protocol fixation

2008 Year 06 Month 30 Day

Date of IRB

2018 Year 11 Month 01 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

na


Management information

Registered date

2018 Year 06 Month 11 Day

Last modified on

2023 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name