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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009772
Receipt No. R000011431
Scientific Title evaluation of new visual acuity test using psychometric function curve in cataract patients
Date of disclosure of the study information 2013/01/13
Last modified on 2014/06/05

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Basic information
Public title evaluation of new visual acuity test using psychometric function curve in cataract patients
Acronym visual acuity test using psychometric function curve
Scientific Title evaluation of new visual acuity test using psychometric function curve in cataract patients
Scientific Title:Acronym visual acuity test using psychometric function curve
Region
Japan

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

Objectives
Narrative objectives1 to compare the results of new visual acuity test using psychometric function curve with the results of other visual function test in cataract patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes visual acuity value
Key secondary outcomes The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25), contrast sensitivity, optical properties of the eye

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cataract surgery
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 patients who have cataract surgery
Key exclusion criteria patients who have ocular diseases other than cataract, patients whose preoperative corrected visual acuity is less than 0.3
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomofusa Yamauchi
Organization San-eikai Tsukazaki Hospital
Division name Department of ophthalmology
Zip code
Address 68-1 Waku Aboshi-ku Himeji Hyogo Japan
TEL 0792728555
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomofusa Yamauchi
Organization San-eikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address 68-1 Waku Aboshi-ku Himeji Hyogo Japan
TEL 0792728555
Homepage URL
Email t.yamauchi@tsukazaki-eye.net

Sponsor
Institute San-eikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization San-eikai Tsukazaki Hospital
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 13 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 Main results already published
Date of protocol fixation
2013 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 13 Day
Last modified on
2014 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011431

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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