UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054914 |
|---|---|
| Receipt number | R000062741 |
| Scientific Title | Investigation of the usefulness of presbyopia correction and visual function on new multifocal contact lens |
| Date of disclosure of the study information | 2024/07/09 |
| Last modified on | 2024/07/09 15:01:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the usefulness of presbyopia correction and visual function on new multifocal contact lens
Acronym
Investigation of the usefulness of presbyopia correction and visual function on new multifocal contact lens
Scientific Title
Investigation of the usefulness of presbyopia correction and visual function on new multifocal contact lens
Scientific Title:Acronym
Investigation of the usefulness of presbyopia correction and visual function on new multifocal contact lens
Region
| Japan |
Condition
Condition
Presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of presbyopia correction with extended depth-of-focus contact lenses (One-Day Acuvue Oasys MAX MF, J&J) in presbyopic patients and its effect on visual function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-distance visual acuity (5m, 3m, 2m, 1m, 0.7m, 0.5m, 0.3m) (monocular and binocular)
Examine the differences before and after wearing the contact lens.
Key secondary outcomes
Contrast sensitivity
Subjective satisfaction
Questionnaire survey
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
Patients who wish to correct presbyopia with contact lenses and have selected extended depth-of-focus contact lenses (One Day Acuvue Oasys MAX Multifocal, Johnson & Johnson Vision Care Company) meet all of the following criteria.
(1) Corneal astigmatism of less than 1.5D
(2) Corrected visual acuity of 1.0 or better
Key exclusion criteria
(1) Patients with organic eye disease (severe dry eye, ocular inflammation, ocular infection, etc.)
(2) Patients with a history of ophthalmic surgery
(3) Patients that the principal investigator determines to be unsuitable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Ophthalmology
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya, Aichi
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson K.K. Vision Care Company
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
Chukyo Eye Clinic, REC
Address
12-23 Sanbonmatsu-cho Atsuta-ku, Nagoya city Aichi
Tel
052-884-7976
rec@chukyogroup.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
中京眼科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 09 | 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
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Presbyopia patients who wish to implant extended depth-of-focus contact lenses (One-Day Acuvue Oasys MAX Multifocal, Johnson & Johnson K.K. Vision Care Company) will be included.
The patients will not wear contact lenses for one week and will be asked to use glasses, and an examination will be conducted before wearing the lenses. The patients will then wear the contact lenses for one week and undergo the same examination after wearing the contact lenses.
The ophthalmological examination and observation items will be compared using the Wilcoxon signed-rank test when the contact lenses are worn and not worn.
The ophthalmological examination and observation items will be as follows:
1. Patient background information including age, gender, ocular history, and presence of ocular complications
2. The following five examinations should be performed before and after wearing contact lenses. Items that cannot be measured should be treated as missing values.
(1) Uncorrected and corrected visual acuity (near, intermediate, and distance)
(2) Subjective refraction power
(3) All-distance visual acuity (TMI-V5, TMI)
(4) Higher-order aberration (OPD scan, Nidek)
(5) Contrast sensitivity (IMO vifa, Crewt Medical Systems, Inc.)
3. Contact lens prescription success rate
4. Subjective satisfaction (rated on a scale of 0 (not satisfied) to 100 (very satisfied) using the VAS scale)
5. Questionnaire survey (using VFQ-25 and J-CLDEQ)
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062741
