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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033175
Receipt No. 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

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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
Email 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
Email hayashi-ken@hayashi.or.jp

Sponsor
Institute Hayashi Eye Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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