UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027329 |
|---|---|
| Receipt number | R000031313 |
| Scientific Title | Binocular visual performance after contralateral implantation of multifocal intraocular lenses with different near additional powers |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2024/05/17 17:40:20 |
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Basic information
Public title
Binocular visual performance after contralateral implantation of multifocal intraocular lenses with different near additional powers
Acronym
Clinical outcomes of implantation of multifocal intraocular lenses with different near additional powers
Scientific Title
Binocular visual performance after contralateral implantation of multifocal intraocular lenses with different near additional powers
Scientific Title:Acronym
Clinical outcomes of implantation of multifocal intraocular lenses with different near additional powers
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether quality of life after implantation of different near additional power is improved
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
contrast sensitivity, stereopsis,halos, glare
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cases without any other ocular diseases
normal stereopsis
cases without history of keratorefractive surgery
Key exclusion criteria
cases with ocular diseases which affect visual acuity
amblyopia
cases with history of ocular surgery
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | Miyajima |
| Last name | Bissenn |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
101-0061
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-5275-1856
bissen@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Ota |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
101-0061
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-5275-1856
Homepage URL
yota@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Dental College Suidobashi Hospital
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo, Japan
Tel
0352751856
yota@tdc.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
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0002939418306652?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0002939418306652?via%3Dihub
Number of participants that the trial has enrolled
56
Results
Bilateral implantation of bifocal intraocular lenses with different near additional powers provides better intermediate vision than implantation of bifocal intraocular lenses with the same additional powers.
Results date posted
| 2024 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who planned cataract surgery with bilateral bifocal intraocular lenses implantation and who had no history of corneal surgery were included.
Participant flow
The intraocular lens with +4.0-D add power was implanted into the 1st eye. Based on the patient preference and outcomes of the first eye, the bifocal intraocular lens for the fellow eye was chosen from among the lens +4.0-D add power, +3.25-D add power, and +2.75-D add power.
Adverse events
nothing
Outcome measures
Three months after the bifocal intraocular lenses implantations, the binocular uncorrected and distance-corrected visual acuities were measured at the distances of 5.0, 1.0, 0.7, 0.5, and 0.3 meters. The binocular contrast sensitivity was measured.Patient satisfaction and symptoms of undesirable optical phenomena were recorded.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031313
