UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021605
Receipt number R000024733
Scientific Title "Analysis of the efficacy of vitrectomy" Analysis of pre-, intra- and post-operative findings in patients who underwent vitrectomy
Date of disclosure of the study information 2016/03/25
Last modified on 2019/03/30 08:41:04

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Basic information

Public title

"Analysis of the efficacy of vitrectomy"
Analysis of pre-, intra- and post-operative findings in patients who
underwent vitrectomy

Acronym

Analysis of the efficacy of vitrectomy

Scientific Title

"Analysis of the efficacy of vitrectomy"
Analysis of pre-, intra- and post-operative findings in patients who
underwent vitrectomy

Scientific Title:Acronym

Analysis of the efficacy of vitrectomy

Region

Japan


Condition

Condition

vitreoretinal disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prognosis of visual function by analysis of pre-, intra- and post-operative findings

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

prognosis of visual function

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with vitreoretinal disease

Key exclusion criteria

none

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Toru
Middle name
Last name Nakazawa

Organization

Tohoku University Graduate School of Medicine

Division name

Ophthalmology

Zip code

980-8574

Address

1-1, Seirho-cho, Aoba-ku, Sendai

TEL

022-717-7294

Email

ntoru@oph.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Fumihiko
Middle name
Last name NItta

Organization

Tohoku University Graduate School of Medicine

Division name

Ophthalmology

Zip code

980-8574

Address

1-1, Seirho-cho, Aoba-ku, Sendai

TEL

022-717-7294

Homepage URL


Email

nitta@oph.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Graduate School of Medicine

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

Department of ophthalmologh, Tohoku Univercity graduate school of medicine

Address

1-1, Seiryo-cho, Aoba-ku, Sendai

Tel

022-717-7294

Email

nitta@oph.med.tohoku.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

2016 Year 03 Month 25 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

Open public recruiting

Date of protocol fixation

2016 Year 02 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We are including cases


Management information

Registered date

2016 Year 03 Month 25 Day

Last modified on

2019 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name