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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023516
Receipt No. 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

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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
Institute Hayashi Eye Hospital
Institute
Department

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
URL(English) https://upload.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


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