UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051055 |
|---|---|
| Receipt number | R000058216 |
| Scientific Title | Assessment of Usefulness for Presbyopic Correction and Visual Function During Extended Depth of Field Contact Lens Wear. |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/09/12 13:18:31 |
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Basic information
Public title
Assessment of Usefulness for Presbyopic Correction and Visual Function During Extended Depth of Field Contact Lens Wear.
Acronym
Assessment of Presbyopic Correction During EDOF CL Wear.
Scientific Title
Assessment of Usefulness for Presbyopic Correction and Visual Function During Extended Depth of Field Contact Lens Wear.
Scientific Title:Acronym
Assessment of Presbyopic Correction During EDOF CL Wear.
Region
| Japan |
Condition
Condition
presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate visual function and subject satisfaction during wearing extended depth of field contact lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity at various distances
Key secondary outcomes
functional visual acuity, contrast sensitivity, satisfaction (VAS scale), QOV (VFQ25, ATIONAL EYE INSTITUTE 42-ITEM REFRACTIVE ERROR QUALITY OF LIFE INSTRUMENT, accommodative microfluctuations
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who selected EDOF CL.
Those who understand the contents of the consent explanation document and their informed consents can be obtained.
Those who have a astigmatism of 1.5D or less.
Those who have corrected visual acuity of 1.0 or better.
Key exclusion criteria
Cases having ophthalmologic diseases such as severe dry eye, ocular inflammatory diseases, ocular infectous diseases, etc.
Cases with a history of ophthalmic surgery.
Cases who are judged to be ineligible for the study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | KAZUNORI |
| Middle name | |
| Last name | MIYATA |
Organization
MIYATA EYE HOSPITAL
Division name
6-3 KURAHARA MIYAKONOJYO MIYAZAKI JAPAN
Zip code
885-0051
Address
6-3 KURAHARA MIYAKONOJYO MIYAZAKI JAPAN
TEL
0986-22-1441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | TOMOKO |
| Middle name | |
| Last name | KAIDA |
Organization
MIYATA EYE HOSPITAL
Division name
medical office
Zip code
885-0051
Address
6-3 KURAHARA MIYAKONOJYO MIYAZAKI JAPAN
TEL
0986221441
Homepage URL
kaida@miyata-med.ne.jp
Sponsor or person
Institute
MIYATA EYE HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
Seed Co.,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
Meiwa Kai Medical Corporation Clinical Research Ethics Review Committee
Address
6-3 KURAHARA MIYAKONOJYO MIYAZAKI JAPAN
Tel
0986-22-1441
ushihama@miyata-med.ne.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
| 2023 | Year | 05 | Month | 15 | 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
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
prospective observational study
Schedule
(i) After entry, the contestant shall, in principle, not wear contact lenses and use spectacles for at least one week before the pre-wear inspection.
(ii) Pre-wearing examination is carried out.
(iii) Wear extended depth-of-focus contact lenses for 1-4 weeks and conduct a post-wear inspection.
Management information
Registered date
| 2023 | Year | 05 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058216
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
