UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018390 |
|---|---|
| Receipt number | R000021296 |
| Scientific Title | Evaluation of refractive correction for perimetric test in eye with multiforcal lens. |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2016/02/23 09:40:57 |
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Basic information
Public title
Evaluation of refractive correction for perimetric test in eye with multiforcal lens.
Acronym
Refractive correction for perimetric test in eye with multiforcal lens.
Scientific Title
Evaluation of refractive correction for perimetric test in eye with multiforcal lens.
Scientific Title:Acronym
Refractive correction for perimetric test in eye with multiforcal lens.
Region
| Japan |
Condition
Condition
healthy participants
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the refractive correction for perimetric test in eye with multiforcal contact lens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mean sensitivity, area-wise mean sensitivity, point-wise sensitivity, mean deviation, visual field index, and pattern standard deviation.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
wearing the bifocal contact lens
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
refractive error +3.00 to -6.00 D,
astigmatic power is less than 1.50 D,
Intraocular pressure is less than 21mmHg,
visual acuity is more than 1.0.
Key exclusion criteria
refractive error is higher than +3.00 and -6.00 D,
astigmatic power is more than 1.50 D,
Intraocular pressure is more than 22mmHg,
visual acuity is less than 0.9
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
Organization
School of Allied health sciences, KITASATO University
Division name
Orhoptics and Visual Science
Zip code
Address
1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan
TEL
042-778-9671
nshoji@ahs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
School of Allied health sciences, KITASATO University
Division name
Orhoptics and Visual Science
Zip code
Address
1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan
TEL
042-778-9671
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
School of Allied health sciences, KITASATO University
Institute
Department
Personal name
Funding Source
Organization
Allied health sciences, KITASATO University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 07 | Month | 23 | 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
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 05 | Day |
Other
Other related information
Method of refractive correction
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021296
