UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056832 |
|---|---|
| Receipt number | R000064954 |
| Scientific Title | Comparison of visual performance among three types of enhanced monofocal intraocular lenses (IOLs) and a standard monofocal IOL; a prospective ramdomized study |
| Date of disclosure of the study information | 2025/01/28 |
| Last modified on | 2025/01/27 14:26:56 |
* 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
Comparison of visual performance among three types of enhanced monofocal intraocular lenses (IOLs) and a standard monofocal IOL; a prospective ramdomized study
Acronym
Comparison among enhanced monofocal IOLs
Scientific Title
Comparison of visual performance among three types of enhanced monofocal intraocular lenses (IOLs) and a standard monofocal IOL; a prospective ramdomized study
Scientific Title:Acronym
Comparison among enhanced monofocal IOLs
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare visual performance among 3 types of higher-order aspheric enhanced monofocal intraocular lenses (IOL) and 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
All patients undergo examinations of binocular or monocular distance-corrected VA from far to near distances, binocular photopic and mesopic contrast VA, and the extent of halo and glare symptoms at 2 months postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The eyes were randomly assigned to 1 of 4 groups according to the IOL types by a clinical research coordinator. Both eyes of all patients undergo phacoemulsification surgery and implantation of 1 of 4 types of IOLs.
1) Johnson & Johnson Eyhance
Interventions/Control_2
2) HOYA Impress
Interventions/Control_3
3) NIDEK NSP-3
Interventions/Control_4
4) Johnson & Johnson Tecnis monofocal
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
Major inclusion criteria are eyes that were scheduled to undergo phacoemulsification surgery with single-piece hydrophobic acrylic IOL implantation in both eyes.
Key exclusion criteria
Exclusion criteria are: 1) pathology of the cornea, macula, or optic nerve, 2) severe opaque media other than cataract, 3) moderate to severe dry eye, 4) corneal astigmatism more than 1.0D, 5) diabetes mellitus, 6) history of ocular surgery or inflammation, 7) eventful cataract surgery 8) difficulty undergoing examination, and 9) patient refusal.
Target sample size
172
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
8120011
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
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
| 2025 | Year | 01 | Month | 28 | 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 | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064954
