UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062402 |
|---|---|
| Receipt number | R000071418 |
| Scientific Title | Effect of refractive astigmatism on visual acuity from far to near distances in eyes with an enhanced monofocal intraocular lens: a randomized study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 12:38:44 |
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Basic information
Public title
Effect of refractive astigmatism on visual acuity from far to near distances in eyes with an enhanced monofocal intraocular lens: a randomized study
Acronym
Effect of astigmatism on VA with an enhanced monofocal IOL
Scientific Title
Effect of refractive astigmatism on visual acuity from far to near distances in eyes with an enhanced monofocal intraocular lens: a randomized study
Scientific Title:Acronym
Effect of astigmatism on VA with an enhanced monofocal IOL
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of refractive astigmatism on distance-corrected visual acuity (VA) at various viewing distances between eyes implanted with an enhanced monofocal intraocular lens (IOL) and eyes implanted with a standard monofocal IOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Against-the-rule astigmatism was simulated by adding cylindrical lenses of 0, 0.5, 0.75, 1.0, and 1.5 diopters (D). Distance-corrected visual acuity (VA) from far to near viewing distances was measured using an all-distance vision tester and compared between groups.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The major inclusion criterion was planned phacoemulsification with implantation of a single-piece hydrophobic acrylic IOL.
Key exclusion criteria
Exclusion criteria were: 1) corneal, macular, or optic nerve pathlogy, 2) opaque media other than cataract, 3) moderate to severe dry eye, 4) diabetes mellitus, 5) pseudoexfoliation syndrome, 6) previous ocular surgery or inflammation, 7) inability to complete examinations, and 8) refusal to participate.
Target sample size
158
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
812-0011
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL
092-431-1680
hayashi-ken@hayashi.or.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
812-0011
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
TEL
092-431-1680
Homepage URL
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hayashi Eye Hospital
Address
4-23-35, Hakataekimae, Hakata-ku, Fukuoka, Japan
Tel
092-431-1680
mihara-seiya@hayashi.or.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
林眼科病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
158
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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All eyes were randomly assigned in a 1:1 ratio to receive either an enhanced monofocal IOL (TECNIS Eyhance OptiBlue; Johnson & Johnson Vision) or a standard monofocal IOL (TECNIS monofocal OptiBlue, Johnson & Johnson Vision).
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071418
