UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034887 |
|---|---|
| Receipt number | R000039703 |
| Scientific Title | Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2020/11/15 22:11:34 |
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Basic information
Public title
Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens
Acronym
Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens
Scientific Title
Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens
Scientific Title:Acronym
Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens
Region
| Japan |
Condition
Condition
Patients (40 to 49 years old) who notice Presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the relationship between the satisfaction level and the functional visual acuity of the wearers with multifocal soft contact lens by comparing the conventional VA with the functional visual acuity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative evaluation of examination during wearing of two kinds of soft contact lenses
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
| 40 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who are aware of a decline in visual acuity of 40 to 49 years old
2) Single focal soft contact lens wearer who wants multifocal soft contact lens
3) Patients who can properly prescribe Lo
4)A patient who understands the contents of the consent document and is able to consent in the document of the person
5)Patient who can come to the observation day by the instruction of the researcher
Key exclusion criteria
1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye
2)Patients who have allergy and infectious ocular conditions.
3)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research
4)Patients judged by other research managers or researchers as inappropriate to implement this research safely
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Ishizuchi Eye Clinic
Division name
Director
Zip code
7920811
Address
1-8-30 Shonaicho Niihama-city Ehime
TEL
0897333069
t-suzuki@ishizuchi-eye-clinic.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Suzuki |
Organization
Ishizuchi Eye Clinic
Division name
Director
Zip code
7920811
Address
1-8-30 Shonaicho Niihama-city Ehime
TEL
0897333069
Homepage URL
t-suzuki@ishizuchi-eye-clinic.jp
Sponsor or person
Institute
Ishizuchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Riverside
Address
2-1Shitijo, chuou-ku, Sapporo
Tel
011-521-2321
m.oota@riversideclinic.or.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
| 2018 | Year | 12 | 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
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039703
