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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034862
Receipt No. 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

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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
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 (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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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