UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040096 |
|---|---|
| Receipt number | R000045592 |
| Scientific Title | Quantitative assessment of periocular changes in the eyes treated by glaucoma drops |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2020/04/07 17:20:57 |
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Basic information
Public title
Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Acronym
Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Scientific Title
Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Scientific Title:Acronym
Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess quantitatively the changes in the eye treated by glaucoma drops
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the interpupillary distance 3 months after continual instillation of glaucoma drops in glaucoma patients
Key secondary outcomes
The change in the interpupillary distance 1 and 6 months after continual instillation of glaucoma drops in glaucoma patients
Visual acuity, Intra ocular pressure, exophthalmos
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
Glaucoma patients who need treatment with eye drops
Key exclusion criteria
the use of topical or systemic
steroid or nonsteroidal anti-inflammatory drugs;
intraocular, ocular surface, eyelid, or periocular surgeries
during the observation period; and a history of disorders
that might have affected the ocular position including strabismus, abnormal thyroid function, and central nervous
system dysfunction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kamiya |
Organization
Asahikawa Medical University
Division name
Ophthalmology
Zip code
078-8510
Address
Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
TEL
0166-65-2111
t-kamiya@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kamiya |
Organization
Asahikawa Medical University
Division name
Ophthalmology
Zip code
078-8510
Address
Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
TEL
0166-65-2111
Homepage URL
t-kamiya@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jichi Medical University
Asahikawa Eye Clinic
Engaru Yamaguchi Eye Clinic
Konnno Suguru Eye Clinic
Wakkanai City Hospital
Nemuro City Hospital
Nayoro City General Hospital
Yakumo General Hospital
Engaru-Kosei General Hospital
Shibetsu City Hospital
Kouiki Monbetsu Hospital
Bihoro Chouritsu Kokuminkenkouhoken Hospital
Okubo Eye Clinic
JCHO Tokyo Shinjuku Medical Center
Takahashi Eye Clinic
Hara Eye Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical Univesity Research Ethics Committee
Address
Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.ac.jp
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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045592
| 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 |
