UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023516
Receipt number R000027053
Scientific Title Binocular visual function of myopic pseudophakic monovision: randomized clinical comparison with bilaterralu myopic patients
Date of disclosure of the study information 2016/08/06
Last modified on 2016/12/21 11:46:59

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Basic information

Public title

Binocular visual function of myopic pseudophakic monovision: randomized clinical comparison with bilaterralu myopic patients

Acronym

Binocular visual function of myopic pseudophakic monovision

Scientific Title

Binocular visual function of myopic pseudophakic monovision: randomized clinical comparison with bilaterralu myopic patients

Scientific Title:Acronym

Binocular visual function of myopic pseudophakic monovision

Region

Japan


Condition

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve near and intermediate vision, we recently began to adjust the postoperative refraction of some myopic patients to near distance in the dominant eyes and intermediate distance in nondominant eyes.Because this method utilizes the basic principle of monovision, we termed this method as a myopic pseuodophakic monovision. The purpose of this study is to examine the binocular visual function of patients with myopic monovision.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Binocular uncorrected and distance-corrected visual acuity (VA) at various distances was measured using the all-distance vision tester (KOWA AS=15), and 2.contrast visual acuity (CAT-2000) and 3.near stereoacuity (Titmus stereo test) were examined.

Key secondary outcomes

4.Refraction, corneal astigmatism
5.Pupil diameter
6.Patient questionnaire...patient satisfaction, spectacle independency


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Sixty myopic patients were randomized to one of two groups: patients whose refraction was targeted to -2.75D in dominant eye and -1.75D in nondominant eye (myopic monovision), and patients whose refraction were targeted to -2.75D bilaterally (non-monovision).

Interventions/Control_2

patients whose refraction were targeted to -2.75D bilaterally (non-monovision).

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

We began screening all consecutive highly or moderately myopic patients scheduled for bilateral cataract surgery at the Hayashi Eye Hospital who wanted to see near distance after cataract surgery. Screening was continued until 60 patients were recruited.

Key exclusion criteria

Exclusion criteria were eyes with any pathology of the optic nerve, macula, or cornea; severe opaque media other than cataract; eyes scheduled for planned extracapsular cataract extraction; a history of previous ocular surgery or inflammation; abnormal ocular position (esophoria or exophoria); pupillary diameter smaller than 4.5 mm after full pupil dilation; patient refusal; and any difficulty with examination or follow-up.

Target sample size

60


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 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



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

2016 Year 08 Month 06 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

2015 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 22 Day

Last follow-up date

2016 Year 08 Month 31 Day

Date of closure to data entry

2016 Year 08 Month 31 Day

Date trial data considered complete

2016 Year 08 Month 31 Day

Date analysis concluded

2016 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 06 Day

Last modified on

2016 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name