UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017904
Receipt number R000020741
Scientific Title Retrospective study for prediction of glaucoma progression
Date of disclosure of the study information 2015/06/16
Last modified on 2020/12/25 17:51:22

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Basic information

Public title

Retrospective study for prediction of glaucoma progression

Acronym

Retrospective study for prediction of glaucoma progression

Scientific Title

Retrospective study for prediction of glaucoma progression

Scientific Title:Acronym

Retrospective study for prediction of glaucoma progression

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate prediction of glaucoma progression in Japanese patients

Basic objectives2

Others

Basic objectives -Others

Progression of visual field loss

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression of visual field loss

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

Patients who visit Fukuiken Saiseikai Hospital during the survey period

Key exclusion criteria

Not applicable

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Nitta

Organization

Fukuiken Saiseikai Hospital

Division name

Ophthalmology

Zip code

918-8503

Address

Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui

TEL

0776-23-1111

Email

k-nitta@fukui.saiseikai.or.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Nitta

Organization

Fukuiken Saiseikai Hospital

Division name

Ophthalmology

Zip code

918-8503

Address

Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui

TEL

0776-23-1111

Homepage URL


Email

k-nitta@fukui.saiseikai.or.jp


Sponsor or person

Institute

Fukuiken Saiseikai Hospital

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuiken Saiseikai Hospital

Address

Funabashi 7-1, Wadanaka-cho, Fukui City, Fukui

Tel

0776-23-1111

Email

somuka@fukui.saiseikai.or.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

福井県済生会病院(福井県)/ Fukuiken Saiseikai Hospital(Fukui Pref.)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 16 Day


Related information

URL releasing protocol

Not applicable

Publication of results

Published


Result

URL related to results and publications

https://www.nature.com/articles/s41598-017-15267-y , https://doi.org/10.2147/OPTH.S247618

Number of participants that the trial has enrolled

312

Results

Refer to published paper

Results date posted

2020 Year 12 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 11 Month 08 Day

Baseline Characteristics

Refer to published paper

Participant flow

Refer to published paper

Adverse events

Refer to published paper

Outcome measures

Refer to published paper

Plan to share IPD

The datasets are not publicly available, but are available from the corresponding author on reasonable request.

IPD sharing Plan description

The datasets are not publicly available, but are available from the corresponding author on reasonable request.


Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 18 Day

Date of IRB

2015 Year 05 Month 18 Day

Anticipated trial start date

2015 Year 05 Month 26 Day

Last follow-up date

2015 Year 10 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study
Prediction of Glaucoma progression
Target sample size : No. of the target patients during the survey period


Management information

Registered date

2015 Year 06 Month 15 Day

Last modified on

2020 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name