UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034862
Receipt number R000039722
Scientific Title Effect of manifest spherical equivalent error on visual acuity at various distances in eyes with a trifocal intraocular lens (IOL): a simulation study
Date of disclosure of the study information 2018/11/12
Last modified on 2018/11/12 11:07:06

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Basic information

Public title

Effect of manifest spherical equivalent error on visual acuity at various distances in eyes with a trifocal intraocular lens (IOL): a simulation study

Acronym

Effect of spherical equivalent error on trifocal intraocular lens

Scientific Title

Effect of manifest spherical equivalent error on visual acuity at various distances in eyes with a trifocal intraocular lens (IOL): a simulation study

Scientific Title:Acronym

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

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

http://www.hayashi.or.jp/hospital/chiken.html

Email

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


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 (Fukuoka)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 12 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

2018 Year 06 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name