UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013733 |
|---|---|
| Receipt number | 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 16:27:29 |
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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
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
n.aizawa@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
