UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062332 |
|---|---|
| Receipt number | R000071155 |
| Scientific Title | A Study on the Efficacy and Safety of Scleral Lens Fitting in Relation to Palpebral Fissure Width |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/24 16:02:34 |
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Basic information
Public title
A Study on the Efficacy and Safety of Scleral Lens Fitting in Relation to Palpebral Fissure Width
Acronym
A Study on the Efficacy and Safety of Scleral Lens Fitting in Relation to Palpebral Fissure Width
Scientific Title
A Study on the Efficacy and Safety of Scleral Lens Fitting in Relation to Palpebral Fissure Width
Scientific Title:Acronym
Efficacy and Safety of Scleral Lens Fitting
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By having healthy adults wear scleral lenses and evaluating changes in palpebral fissure width before and after lens wear as the primary endpoint, we will investigate the effect of scleral lens wear on palpebral fissure widening, thereby obtaining basic findings that will contribute to future clinical applications and trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Eyelid Width Before and After Wearing Scleral Contact Lenses
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In this study, scleral lenses will be fitted to both eyes of healthy adults.
The lenses will be appropriately selected and fitted according to the shape of each subject's cornea and inserted while filled with sterile saline solution. Insertion will be performed under the supervision of an ophthalmologist or a sufficiently trained healthcare professional. Wearing time will be kept to the minimum necessary for evaluation, and palpebral width measurements and ophthalmic examinations will be performed before and after lens insertion.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 20 or older at the time of obtaining informed consent
Individuals with no notable abnormalities in their ophthalmic history (regardless of whether they wear corrective lenses, but who do not have any active diseases)
Individuals deemed capable of wearing scleral lenses and undergoing various examinations in one or both eyes
Individuals who have received a thorough explanation of the study and have provided written informed consent
Key exclusion criteria
Individuals with corneal disorders (such as corneal epithelial disorders, keratitis, or keratoconus)
Individuals with active ocular infections or inflammatory conditions (such as conjunctivitis or blepharitis)
Individuals for whom it is determined that wearing scleral lenses could worsen symptoms, such as those with severe dry eye
Individuals for whom proper evaluation is difficult due to eyelid abnormalities (severe ptosis, lagophthalmos, blepharospasm, etc.)
Individuals with a known history of intolerance or allergy to contact lenses
Any other individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Yanai |
Organization
Tokushima University Graduate School,
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
7700812
Address
3-18-15 Kuramoto, Tokushima
TEL
0886317163
9620137@gmail.com
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Yanai |
Organization
Tokushima University Graduate School
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
7700812
Address
3-18-15 Kuramoto
TEL
0886317163
Homepage URL
9620137@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
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
Tokushima University Hospital Research Ethics Committee for Life Sciences and Medicine
Address
2-50-1, Kuramoto, Tokushima
Tel
0886317163
mailto:bethics1@tokushima-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071155
