UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026422 |
|---|---|
| Receipt number | R000030275 |
| Scientific Title | Scleral Lens for Japanese Severe Dry Eye and Corneal Irregular Astigmatism Patients |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/16 12:38:51 |
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Basic information
Public title
Scleral Lens for Japanese Severe Dry Eye and
Corneal Irregular Astigmatism Patients
Acronym
Scleral Lens for Japanese Patients
Scientific Title
Scleral Lens for Japanese Severe Dry Eye and
Corneal Irregular Astigmatism Patients
Scientific Title:Acronym
Scleral Lens for Japanese Patients
Region
| Japan |
Condition
Condition
Dry Eye,
Corneal irregular astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of screlal lens for Japanese Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Acuity(1 month after)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Scleral lens
(Elara Lens and Europa Lens)
sMap3D
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dry Eye
Corneal irregular astigmatism
Key exclusion criteria
unable to Scleral lens
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohji Nishida |
Organization
Osaka University Medical School
Division name
Ophthalmology
Zip code
Address
2-2, Yamadaoka Suita
TEL
0668793456
knishida@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motokazu Tsujikawa |
Organization
Osaka University Medical School
Division name
Ophthalmology
Zip code
Address
2-2, Yamadaoka Suita
TEL
0668793456
Homepage URL
moto@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Visionary Optics
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2017 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030275
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
