UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039982
Receipt number R000045588
Scientific Title Evaluation of intraocular pressure measured by Icare ic200
Date of disclosure of the study information 2020/04/18
Last modified on 2020/03/30 16:21:04

* 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

Evaluation of intraocular pressure measured by Icare ic200

Acronym

Evaluation of intraocular pressure measured by Icare ic200

Scientific Title

Evaluation of intraocular pressure measured by Icare ic200

Scientific Title:Acronym

Evaluation of intraocular pressure measured by Icare ic200

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)Evaluation of intraocular pressure(IOP) measured by Icare ic200.
2) Comparison of IOP with Goldmann tonometer and IcarePRO.
3) Estimations of IOP rise induced by posture change in patients with glaucoma.

Basic objectives2

Others

Basic objectives -Others

Posture induced IOP and its'relation with filtering surgery.

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1) Agreement and reproducibility among tonometers.

2) Posture induced IOP.

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with glaucoma.

Key exclusion criteria

Patients who are unacceptable with Goldmann applanation tonometer or rebound tonometer.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Nakakura
Middle name
Last name Shunsuke

Organization

Saneikai Tsukazaki Hospital

Division name

Department of Ophthalmology

Zip code

6711227

Address

Aboshi waku 68-1

TEL

079-272-8555

Email

shunsukenakakura@yahoo.co.jp


Public contact

Name of contact person

1st name Nakakura
Middle name
Last name Shunsuke

Organization

Saneikai Tsukazaki Hospital

Division name

Ophtahlmology

Zip code

6711227

Address

Aboshi waku 68-1

TEL

079-272-8555

Homepage URL


Email

shunsukenakakura@yahoo.co.jp


Sponsor or person

Institute

Saneikai Tsukazaki Hospital

Institute

Department

Personal name



Funding Source

Organization

Saneikai Tsukazaki Hospital

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

Saneikai Tsukazaki Hospital

Address

Aboshi waku 68-1

Tel

079-272-8555

Email

m.kosenbo@tsukazkai-eye.net


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 04 Month 18 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

Preinitiation

Date of protocol fixation

2020 Year 03 Month 30 Day

Date of IRB

2020 Year 04 Month 17 Day

Anticipated trial start date

2020 Year 04 Month 18 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 03 Month 30 Day

Last modified on

2020 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=R000045588


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name