UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014166
Receipt number R000016501
Scientific Title To evaluate outcomes after surgery for glaucoma.
Date of disclosure of the study information 2014/06/05
Last modified on 2021/06/09 19:35:04

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Basic information

Public title

To evaluate outcomes after surgery for glaucoma.

Acronym

To evaluate outcomes after surgery for glaucoma.

Scientific Title

To evaluate outcomes after surgery for glaucoma.

Scientific Title:Acronym

To evaluate outcomes after surgery for glaucoma.

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate outcomes after surgery for glaucoma. To identify factors correlated with outcomes after surgery for glaucoma.

Basic objectives2

Others

Basic objectives -Others

To identify factors correlated with visual outcomes after surgery for glaucoma.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Factors correlated with outcomes after surgery for glaucoma

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 who agreed with participating in this study.
Patients treated by surgery for glaucoma.

Key exclusion criteria

Patients who disagreed with participating in this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yamashita
Middle name
Last name Hidetoshi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code

990-2331

Address

2-2-2 Iidanishi, Yamagata

TEL

023-628-5374

Email

hyama-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yamashita
Middle name
Last name Hidetoshi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code

990-2331

Address

2-2-2 Iidanishi, Yamagata

TEL

023-628-5374

Homepage URL


Email

hyama-tky@umin.ac.jp


Sponsor or person

Institute

Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethical Review Committee of Yamagata University Faculty of Medicine

Address

2-2-2, Iida-nishi, Yamagata

Tel

023-628-5047

Email

ikekenkyu@jm.kj.yamagata-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

山形大学医学部附属病院(山形県)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://doi.org/10.1371/journal.pone.0249898

Number of participants that the trial has enrolled

27

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 04 Month 15 Day

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

2014 Year 05 Month 19 Day

Date of IRB

2014 Year 05 Month 19 Day

Anticipated trial start date

2014 Year 06 Month 06 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We observe outcomes after surgery for glaucoma.
We evaluate correlation between systemic and local factors and outcomes after surgery for glaucoma.


Management information

Registered date

2014 Year 06 Month 04 Day

Last modified on

2021 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016501


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name