UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057605 |
|---|---|
| Receipt number | R000065818 |
| Scientific Title | Quantitative Study of the Effect of High-Added-Value Contact Lenses on Chair Time |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/04/14 17:05:36 |
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Basic information
Public title
Quantitative Study of the Effect of High-Added-Value Contact Lenses on Chair Time
Acronym
Quantitative Study of the Effect of High-Added-Value Contact Lenses on Chair Time
Scientific Title
Quantitative Study of the Effect of High-Added-Value Contact Lenses on Chair Time
Scientific Title:Acronym
Quantitative Study of the Effect of High-Added-Value Contact Lenses on Chair Time
Region
| Japan |
Condition
Condition
Ophthalmology refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine the chair time required to prescribe contact lenses for patients with normal contact lenses and high-added-value lenses (toric and multifocal contact lenses) prescriptions, and to examine the impact of contact lens type on chair time in terms of time efficiency.
Basic objectives2
Others
Basic objectives -Others
Impact of contact lens type on chair time in terms of time efficiency.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required for the contact lens prescription
Key secondary outcomes
1. Time required from measurement by autorefractometer to interview and visual acuity measurement
2. Time required for lens explanation
3. Time required for test lens fitting
4. Time required for examiner to confirm fitting (can be omitted if not performed)
5. Time required to confirm visual acuity with contact lenses
6. Time required to confirm contact lens fitting by ophthalmologist through consultation
7. Prescription success rate
8. Subjective satisfaction (VAS scale)
9. Questionnaire survey (VFQ-25, J-CLDEQ8)
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
| 12 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who requested a contact lens prescription
2. Those who chose regular contact lenses or value-added lenses (toric, multifocal contact lenses)
3. Those who requested a binocular contact lens prescription for refractive error
4. Corrected visual acuity of 1.0 or better
5. One Day Acuvue, One Day Acuvue Toric, or One Day Acuvue Multifocal (by J&J) were used.
Key exclusion criteria
1. Cases with organic eye disease (severe dry eye, ocular inflammatory disease, ocular infection, etc.)
2. Cases with a history of eye surgery
3. Cases deemed unsuitable by the principal investigator
Target sample size
120
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-city, Aichi, JAPAN
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-city, Aichi, JAPAN
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Chukyo Eye Clinic
Organization
Division
Category of Funding Organization
Self funding
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
12-22 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
眼科スターアイクリニック（東京都）
北里大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 14 | 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
| 2025 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To prospectively examine the chair time required to prescribe contact lenses for patients with normal contact lenses and high-added-value lenses (toric and multifocal contact lenses) prescriptions, and to examine the impact of contact lens type on chair time in terms of time efficiency.
Management information
Registered date
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065818
