UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040302
Receipt number R000045979
Scientific Title Effects on retinal blood vessel density after trabeculectomy
Date of disclosure of the study information 2020/06/01
Last modified on 2023/11/10 13:25:48

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Basic information

Public title

Effects on retinal blood vessel density after trabeculectomy

Acronym

Effects on retinal blood vessel density after trabeculectomy

Scientific Title

Effects on retinal blood vessel density after trabeculectomy

Scientific Title:Acronym

Effects on retinal blood vessel density after trabeculectomy

Region

Japan


Condition

Condition

Glaucoma patients

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine retinal blood vessel density, visual field and retinal thickness in glaucoma.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Retinal blood vessel density

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

Glaucoma patients

Key exclusion criteria

No ocular abnormalities except glaucoma

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Sawada

Organization

Gifu University Graduate School of Medicine

Division name

Ophthalmology

Zip code

501-1194

Address

1-1 Yanagido, Gifu-shi, Japan

TEL

058-230-6000

Email

sawadaa-gif@umin.ac.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Inuzuka

Organization

Gifu University Graduate School of Medicine

Division name

Ophthalmology

Zip code

501-1194

Address

1-1 Yanagido, Gifu-shi, Japan

TEL

058-230-6000

Homepage URL


Email

inuzuka08@yahoo.co.jp


Sponsor or person

Institute

Gifu University

Institute

Department

Personal name



Funding Source

Organization

Gifu University

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

Gifu University Graduate School of Medicine

Address

1-1 Yanagido, Gifu-shi, Japan

Tel

058-230-6000

Email

sawadaa-gif@umin.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

2020 Year 06 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


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

2019 Year 03 Month 07 Day

Date of IRB

2019 Year 03 Month 07 Day

Anticipated trial start date

2019 Year 03 Month 07 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2020 Year 05 Month 03 Day

Last modified on

2023 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name