UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013051 |
|---|---|
| Receipt number | R000013995 |
| Scientific Title | Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2019/01/25 18:38:56 |
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Basic information
Public title
Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Acronym
Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment
Scientific Title
Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment: Pilot Study
Scientific Title:Acronym
Topical Isopropyl Unoprostone for Rhegmatogenous Retinal Detachment
Region
| Japan |
Condition
Condition
rhegmatogenous retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of topical Isopropyl Unoprostone for the recovery of photoreceptors after vitrectomy for rhegmatogenous retinal detachment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Best-corrected visual acuity
Key secondary outcomes
retinal sensitivity
thickness of outer nuclear layer
macular volume
fundus auto fluorescence
VFQ-25
color sense
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Unoprostone eye drops 0.15%
Interventions/Control_2
placebo eye drops
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
macula-off rhegmatogenous retinal detachment
best-corrected visual acuity <0.3
duration of macula-off retinal detachment < 1week
after successful vitrectomy
Key exclusion criteria
severe cataract
macular disease including pathologic myopia
past history of retinal detachment
past history of intraocular surgery
glaucoma, neuropathy
allegy to Unoprostone
past history of topical Unoprostone
pregnancy, breast feeding
severe cardiovascular disease, renal feilure,
uncontrolled diabetes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology and Visual Science
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
babatakayuki@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Baba |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology and Visual Science
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
babatakayuki@nifty.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
R-tec Ueno
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013995
| 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 |
