UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057855 |
|---|---|
| Receipt number | R000066131 |
| Scientific Title | Postoperative visual function of hybrid monovision |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/05/13 16:39:32 |
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Basic information
Public title
Postoperative visual function of hybrid monovision
Acronym
Postoperative visual function of hybrid monovision
Scientific Title
Postoperative visual function of hybrid monovision
Scientific Title:Acronym
Postoperative visual function of hybrid monovision
Region
| Japan |
Condition
Condition
cataract, presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative visual function of two types of multifocal intraocular lenses, FineVision HP and LENTIS comfort, in hybrid monovison, which combines the advantages of inserting a monofocal intraocular lens in the dominant eye and a multifocal intraocular lens in the non-dominant eye during cataract surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance vision, near vision, postoperative complications
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects were 16 hybrid monovision patients (32 eyes, 16 patients) who underwent cataract surgery in both eyes at our hospital and were followed up for more than 3 months after surgery using Finevision HP (group F) and 33 hybrid monovision patients (66 eyes, 33 patients) using the LENTIS comfort group (group L).
Key exclusion criteria
Dropout during the observation period or failure to give consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Koshimizu |
Organization
Sanno Hospital
Division name
ophthalmology
Zip code
1070052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023151
koshimana@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Koshimizu |
Organization
Sanno Hospital
Division name
ophthalmology
Zip code
1070052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023151
Homepage URL
koshimana@iuhw.ac.jp
Sponsor or person
Institute
Sanno Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanno Hospital
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
Junwakai Ethics Committee
Address
8-10-16 Akasaka, Minato-ku, Tokyo
Tel
0334023151
koshimana@iuhw.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
| 2025 | Year | 05 | Month | 15 | 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
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Purpose] To compare the postoperative visual function of two types of multifocal intraocular lenses, FineVision HP and LENTIS comfort, in hybrid monovision, which combines the advantages of each by inserting a monofocal intraocular lens in the dominant eye and a multifocal intraocular lens in the non-dominant eye during cataract surgery.
[Subjects and Methods] The subjects were 16 hybrid monovision cases (32 eyes, 16 cases) in the Finvision HP group (F group) and 33 hybrid monovision cases (66 eyes, 33 cases) in the LENTIS comfort group (L group) who underwent cataract surgery in both eyes at our hospital and were followed up for more than 3 months after surgery. The average age was 67.3 years in the F group and 68.9 years in the L group, and the postoperative visual function was evaluated retrospectively.
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066131
