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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013733
Receipt No. R000015719
Scientific Title Observational study to investigate the effects of prostaglandin analogue-induced improved retinal blood flow on the development of visual field damage in patients with preperimetric glaucoma
Date of disclosure of the study information 2014/04/16
Last modified on 2018/03/16

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Basic information
Public title Observational study to investigate the effects of prostaglandin analogue-induced improved retinal blood flow on the development of visual field damage in patients with preperimetric glaucoma
Acronym Pathological study in preperimetric glaucoma
Scientific Title Observational study to investigate the effects of prostaglandin analogue-induced improved retinal blood flow on the development of visual field damage in patients with preperimetric glaucoma
Scientific Title:Acronym Pathological study in preperimetric glaucoma
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pathological development of glaucoma in a prospective observational study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Onset of visual field abnormal
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 1
Patients able to visit the medical institution at pre-defined visits as instructed by the physician, who are willing to participate in the study, and who are able to provide written informed consent

2
Patients requiring treatment as assessed by the physician

3
Patients with intraocular pressure of 21mmHg or lower, with observed retinal thinning, but without visual field damage

4
Patients with Grade 3 or 4 angles according to the Shaffer classification
Key exclusion criteria Patients assessed as inappropriate to be enrolled in this observational study by the physician
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Aizawa
Organization Tohoku Univ. Hospital
Division name Ophthalmology
Zip code
Address Seiryocho 1-1, Aobaku, Sendai city, Miyagi Japan
TEL 022-717-7294
Email n.aizawa@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Aizawa
Organization Tohoku Univ. Hospital
Division name Ophthalmology
Zip code
Address Seiryocho 1-1, Aobaku, Sendai city, Miyagi Japan
TEL 022-717-7294
Homepage URL
Email n.aizawa@oph.med.tohoku.ac.jp

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Software Development Co., Ltd.
AC MEDICAL INC.
Softcare Ltd.
Medical TOUKEI Corp.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東北大学病院
かとう眼科
やすい眼科

Tohoku Univ. Hospital, Kato eye clinic, Yasui eye clinic

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 16 Day

Related information
URL releasing protocol http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188692
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5782826/
Number of participants that the trial has enrolled
Results
Aizawa N et.al. PLoS One. 2017;12: e0188692

Shiga Y et.al. Transl Vis Sci Technol. 2018; 7: 11.
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 Completed
Date of protocol fixation
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information to investigate the effect of "prostaglandin analogue-induced retinal blood-flow improving" on prevention for progression of visual field damage in glaucoma patients.

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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