UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
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	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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