UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033175 |
|---|---|
| Receipt number | R000037833 |
| Scientific Title | Comparison of visual outcomes between bilateral implantation of a trifocal intraocular lens (IOL) and combined implantation of a bifocal IOL with different near addition power: a prospective nonrandomized study |
| Date of disclosure of the study information | 2018/06/28 |
| Last modified on | 2018/06/28 11:32:03 |
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Basic information
Public title
Comparison of visual outcomes between bilateral implantation of a trifocal intraocular lens (IOL) and combined implantation of a bifocal IOL with different near addition power: a prospective nonrandomized study
Acronym
Bilateral trifocal IOLs versus
combined bifocal IOLs
Scientific Title
Comparison of visual outcomes between bilateral implantation of a trifocal intraocular lens (IOL) and combined implantation of a bifocal IOL with different near addition power: a prospective nonrandomized study
Scientific Title:Acronym
Bilateral trifocal IOLs versus
combined bifocal IOLs
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare binocular visual outcomes between patients implanted bilaterally with a new trifocal intraocular lens (IOL) and patients implanted with bifocal IOLs having +3.0 diopter (D) near addition power in the dominant eye and +4.0D in the nondominant eye.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Binocular uncorrected and corrected visual acuity (VA) at various distances measured using the all-distance vision tester (KOWA AS-15),
2) Contrast visual acuity (CAT-2000) with and without glare,
3) Near stereoacuity (Titmus stereo test),
4) Number (%) of patients who reported glare and halo symptoms
5) Wavefront higher-order aberrations (HOAs); total, coma-like, and spherical-like HOAs
6) Pupil diameter, corneal astigmatism, manifest spherical equivalent value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A trifocal IOL group (n=32) implanted bilaterally with a new trifocal IOL (Alcon PanOptix; TFNT00).
Interventions/Control_2
A combined bifocal group (n=46) implanted with a bifocal IOL with +3.0D near addition power (SN60D1) in the dominant eye and +4.0D near addition power (SN60D3) in the nondominant eye.
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
All patients who elected to undergo bilateral phacoemulsification and implantation of multifocal IOLs
Key exclusion criteria
Preoperative exclusion criteria were patients with any pathology of the cornea, macula or optic nerve; opaque media other than cataract; history of ocular inflammation or surgery; corneal astigmatism of 1.0 D or more; marked irregular corneal astigmatism; amblyopia; patients who had participated in another clinical trial; and any difficulties with examinations, analyses, or follow-up. Intraoperative exclusion criteria were a small pupillary diameter that required pupil expansion procedures and eventful surgery.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
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 | |
| Middle name | |
| Last name | Ken Hayashi |
Organization
Hayashi Eye Hospital
Division name
Department of Ophthalmology
Zip code
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
Address
Tel
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）Hayashi Eye Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 18 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 04 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037833
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| Registered date | File name |
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| Registered date | File name |
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