UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045430 |
|---|---|
| Receipt number | R000051869 |
| Scientific Title | Actual condition of refractive correction and its influences on the near task and the systemic health related indices in presbyopia age contact lens users |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2025/03/13 13:37:34 |
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Basic information
Public title
Actual condition of refractive correction and its influences on the near task and the systemic health related indices in presbyopia age contact lens users
Acronym
Actual condition of refractive correction and its influences on the near task and the systemic health related indices in presbyopia age contact lens users
Scientific Title
Actual condition of refractive correction and its influences on the near task and the systemic health related indices in presbyopia age contact lens users
Scientific Title:Acronym
Actual condition of refractive correction and its influences on the near task and the systemic health related indices in presbyopia age contact lens users
Region
| Japan |
Condition
Condition
Presbyopia
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual refractive correction in pre-presbyopia or presbyopia patients who use monofocal soft contact lens without glasses for near correction and to evaluate their satisfaction and the influence on their quality of life.
Basic objectives2
Others
Basic objectives -Others
To determine proper indications for treatment of presbyopia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- refraction
- objective accommodation amplitude
- spectacles usage
- distance and near visual acuity
- questionnaires (Near activity vision questionnaires, subjective happiness scale, quality of sleep)
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- monofocal soft contact lense users
- Not using spectacles daily
- Best corrected visual acuity => 0.8 in both eyes
-
Key exclusion criteria
- Severe dry eye, severe allergic conjunctivitis
- Post refractive surgery
- corneal disease including keratoconus
- Those who are determined inappropriate by the researchers
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
kazunonegishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Ophthalmological Optics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University, Kyoto Prefectural University, Osaka University, University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
北里大学医療衛生学部（神奈川県）
京都府立医科大学（京都府）
大阪大学大学院視覚先端医学寄附講座（大阪府）
筑波大学医学医療系眼科（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Questionnaire :
Contact Lens Dry Eye Questionnaire, Near Activity Visual Questionnaire, Subjective Happiness Scale, Quality of sleep
2) Visual function test:
- dominant eye
- objective refraction
- pupil size (Far, Near)
- objective accommodation amplitude
- distance and Near visual acuities (5m, 40cm)
- MNREAD-J
Management information
Registered date
| 2021 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051869
