UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042550 |
|---|---|
| Receipt number | R000048571 |
| Scientific Title | Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2020/11/25 19:28:00 |
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Basic information
Public title
Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Acronym
Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Scientific Title
Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Scientific Title:Acronym
Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Region
| Japan | Australia |
Condition
Condition
Corneal Irregularities
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with corneal disease and prescribed HCL at our institution and at Innovative Eyecare (Adelaide, Australia), the type, size, and material of HCLs were reviewed backward from the medical records for visual acuity, corneal shape, aberrations, daily vision, and patient satisfaction, as well as the effect on visual function. The aim of this study is to identify the factors that give The findings from this study are expected to further improve the accuracy of visual function in HCL in ocular corneal disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the type, size, and material of HCLs
visual acuity
corneal shape
aberrations
vision
patient satisfaction
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Corneal Irregularities
Key exclusion criteria
Intraocular Surgery
Eye diseases such as allergies
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YUKINOBU |
| Middle name | |
| Last name | OKAJIMA |
Organization
Toho University Omori medical center
Division name
Ophthalmology
Zip code
143-8451
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
yukinobu.okajima@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinobu |
| Middle name | |
| Last name | Okajima |
Organization
Toho University Omori medical center
Division name
Ophthalmology
Zip code
143-8451
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
Homepage URL
yukinobu.okajima@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori medical center
Address
6-11-1 omorinishi otaku
Tel
03-3762-4151
yukinobu.okajima@med.toho-u.ac.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
東邦大学医療センター大森病院, Innovative eye care
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 25 | 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
55
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
Main results already published
Date of protocol fixation
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048571
| 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 |
