UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009207 |
|---|---|
| Receipt number | R000010310 |
| Scientific Title | study for correlation between genetic polymorphism of FP receptor and effect of prostaglandin treatment on preperimetric glaucoma |
| Date of disclosure of the study information | 2012/10/29 |
| Last modified on | 2015/05/02 21:13:45 |
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Basic information
Public title
study for correlation between genetic polymorphism of FP receptor and effect of prostaglandin treatment on preperimetric glaucoma
Acronym
correlation between genetic polymorphism of FP receptor and effect of prostaglandin treatment on glaucoma
Scientific Title
study for correlation between genetic polymorphism of FP receptor and effect of prostaglandin treatment on preperimetric glaucoma
Scientific Title:Acronym
correlation between genetic polymorphism of FP receptor and effect of prostaglandin treatment on glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relatioinship between prostaglandin receptor and fundus blood-flow responding to prostaglandin eyedrops.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
single nucleotide polymorphisms (SNP)of FP receptor and endothelin A/B receptor
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Over age 20 , under age 80.
2 male or femal.
3 Gonioscopy classification of Shaffer 3 or 4.
4 no corneal abnormalities that may interfere measurement of intraocular pressure by Glodman applanation tonometer
5 no retinal disease that can affectnerve fiber layer thickness.
(no history of laser treatment on retina)
6 not secondary glaucoma.
7 phakic or pseudophakic eye
8 spherical equivalent is within +3 to -8D
9 corrected visual acuity>= 20/20
10 intraocular pressure <= 21 mmHg identified twice within six months.
11 more than 1 segment detected as <5% percentile at 6,7,8,10,11 or 12 o'clock segmentation in cpRNFLT analysis by OCT,
examed twice within 6 months.
12 glaucomatous visual field abnormality is not observed by Humphery Feile Analyzer(HFA) within six months, also the result is reliable.
Key exclusion criteria
case without consent, or
Patients assessed as inappropriate to be enrolled in this observational study by the physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu, Morin |
Organization
Tohoku Univ. Hospital
Division name
ophthalmology
Zip code
Address
Seiryocho 1-1, Aobaku, Sendai city
TEL
022-7177294
ryu@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu, Morin |
Organization
Tohoku Univ. Graduate school of medicine
Division name
ophthalmology
Zip code
Address
Seiryocho 1-1, Aobaku, Sendai city
TEL
022-7177294
Homepage URL
ryu@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of ophthalmology, Tohoku Univ. Graduate School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
this is a prospective, case-control observatiional study.
Management information
Registered date
| 2012 | Year | 10 | Month | 29 | Day |
Last modified on
| 2015 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010310
