UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020653 |
|---|---|
| Receipt number | R000023836 |
| Scientific Title | The Changes in Functional Visual Acuity and Corneal Epithelium Disorder with Eye Drops in Glaucoma Patients |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2016/01/27 13:58:27 |
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Basic information
Public title
The Changes in Functional Visual Acuity and Corneal Epithelium Disorder with Eye Drops in Glaucoma Patients
Acronym
The Changes in Functional Visual Acuity with Eye Drops in Glaucoma Patients
Scientific Title
The Changes in Functional Visual Acuity and Corneal Epithelium Disorder with Eye Drops in Glaucoma Patients
Scientific Title:Acronym
The Changes in Functional Visual Acuity with Eye Drops in Glaucoma Patients
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish decreasing in Functional Visual Acuity in glaucoma patients with corneal epithelium disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Visual Acuity
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Possible routine visit to a clinic
Possible obtain patient's consent
Key exclusion criteria
Patient with Dry Eye
-20dB > in Humphrey Field Analyzer
0.1> in Corrected Visual Acuity
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naito Tomoko |
Organization
Okayama University
Division name
ophthalmology
Zip code
Address
2-5-1, Shikata-Cho, Kita-Ku, Okayama, Okayama, Japan
TEL
81-86-235-7297
opth@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujiwara Miyuki |
Organization
Okayama University
Division name
Ophthalmology
Zip code
Address
2-5-1, Shikata-Cho, Kita-Ku, Okayama, Okayama, Japan
TEL
81-86-235-7297
Homepage URL
opth@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
object:Patients who meet the criteria between Nov.2015 and Nov. 2016.
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023836
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
