UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054667 |
|---|---|
| Receipt number | R000062442 |
| Scientific Title | Comparison of Stereopsis of Patients with Monovision, Patients Implanted with Trifocal IOLs and Monofocal IOLs |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/14 15:03:21 |
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Basic information
Public title
Comparison of Stereopsis of Patients with Monovision, Patients Implanted with Trifocal IOLs and Monofocal IOLs
Acronym
Comparison of stereopsis after IOL implantation
Scientific Title
Comparison of Stereopsis of Patients with Monovision, Patients Implanted with Trifocal IOLs and Monofocal IOLs
Scientific Title:Acronym
Comparison of stereopsis after IOL implantation
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although multifocal intraocular lenses (IOLs) and the monovision method are available options for achieving good uncorrected vision after cataract surgery, there are few reports on their impact on stereoacuity. Therefore, this study aims to compare and evaluate the stereoacuity from distance to near in patients with trifocal IOLs, monovision, and monofocal IOLs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients who underwent cataract surgery and stereoacuity testing were selected, and data were collected by reviewing their medical records. Stereoacuity was measured at distances of 0.3m, 0.5m, 0.7m, 3m, and 5m using the OCULUS Binoptometer 4P.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent cataract surgery with implantation of trifocal IOL and monofocal IOL.
Key exclusion criteria
Patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Medical Corporation Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, Japan
TEL
011-864-4656
ohashi@rainbow.ne.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Medical Corporation Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, Japan
TEL
011-864-4656
Homepage URL
ohashi@rainbow.ne.jp
Sponsor or person
Institute
Medical Corporation Ohashi Eye Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
Tel
052-884-7976
irb@chukyomedical.co.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
| 2024 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Unpublished
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
204
Results
Multifocal Group had significantly better stereoacuity than Monofocal Group and Monovision Group at every distance(p<0.05).
Results date posted
| 2024 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
70 patients in multifocal group, 103 patients in monofocal group, and 31 patients in monovision group. Mean age of Multifocal Group, Monofocal Group and Monovision Group were 64.3, 73.3 and 73.6 years, respectively.
Participant flow
The inclusion criteria were no pathology other than cataract, and postoperative best spectacle-corrected distance visual acuity 20/20 or better (logMAR 0).
Adverse events
None
Outcome measures
Stereo acuity measured at distances of 0.3m, 0.5m, 0.7m, 3m and 5m using Binoptometer 4P.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are many studies comparing near stereoacuity, but few have compared stereoacuity at near, intermediate, and far distances. In this study, we used the Binoptometer 4P to measure stereoacuity at distances of 0.3m, 0.5m, 0.7m, 3m, and 5m. stereopsis is measured without correction for the trifocal and monovision groups, while for the monofocal group, measurements were taken with correction at each distance. We then compare and evaluate the stereoacuity at each distance.
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062442
