UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of manifest spherical equivalent error on visual acuity at various distances in eyes with a trifocal intraocular lens (IOL): a simulation study
Title of the study (Brief title)	Effect of spherical equivalent error on trifocal intraocular lens
Region	Japan

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of manifest spherical equivalent error on all-distance visual acuity (VA) in eyes that received a trifocal IOL (Alcon PanOptix; TFT00) after simulating spherical equivalent error by adding various degrees of spherical lens.
Basic objectives2	Others
Basic objectives -Others	Nearsightedness, emmetropia and hypermetropia are simulated by adding various degrees of spherical lens. and the visual acuity (VA) which can be put in those refraction states is measured.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Monocular corrected visual acuity (VA) at various distances was measured using the all-distance vision tester (KOWA AS-15) after simulation of spherical equivalent error. 1) +1.0D addition simulating -1.0D myopia 2) +0.5D addition simulating -0.5D myopia 3) 0D addition simulating emmetropia 4)-0.5D addition simulating +0.5D hyperopia 5) -1.0D addition simulating +1.0D hyperopia
Key secondary outcomes	Pupil diameter, corneal astigmatism, manifest spherical equivalent value

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Sixty eyes of 30 patients who underwent bilateral implantation of a trifocal IOL (Alcon PanOptix; TFNT00) were enrolled
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; and any difficulties with examinations or follow-up. Intraoperative exclusion criteria were a small pupillary diameter that required pupil expansion procedures and eventful surgery.
Target sample size	30

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	http://www.hayashi.or.jp/hospital/chiken.html
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 (Fukuoka)

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 01 Day
Anticipated trial start date	2018 Year 06 Month 13 Day
Last follow-up date	2018 Year 09 Month 27 Day
Date of closure to data entry	2018 Year 09 Month 27 Day
Date trial data considered complete	2018 Year 10 Month 12 Day
Date analysis concluded	2018 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Sixty eyes of 30 patients who underwent bilateral implantation of the trifocal IOL was sequentially included in the study between June 13 and September 27, 2018.

Management information
Registered date	2018 Year 11 Month 12 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039722