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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000617
Receipt No. R000000749
Scientific Title The study for improvement of visual function and quality of vision after ophthalmic surgeries
Date of disclosure of the study information 2007/02/26
Last modified on 2018/07/30

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Basic information
Public title The study for improvement of visual function and quality of vision after ophthalmic surgeries
Acronym The Study for improvement of visual function and quality of vision after ophthalmic surgeries
Scientific Title The study for improvement of visual function and quality of vision after ophthalmic surgeries
Scientific Title:Acronym The Study for improvement of visual function and quality of vision after ophthalmic surgeries
Region
Japan

Condition
Condition ocular diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test improvement of visual functions, quality of life (QOL), and quality of vision (QOV) after intraocular and extraocular surgeries.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pre and postoperative assessment for visual functions including measurements of visual acuity, refractive error, corneal curvature, corneal thickness, axial length, visual field, and macular pigment density; fundus evaluations by using fundus photography and optical coherence tomography. Pre, 3 months, and 12 months postoperative assessment for QOL and QOV by using SF-36 and NEI VFQ-25, respectively, questionaires.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cataract surgery
1.2007-12.2011
Interventions/Control_2 glaucoma surgery
1.2007-12.2011
Interventions/Control_3 vitreo-retinal surgery
1.2007-12.2011
Interventions/Control_4 extraocular surgery
1.2007-12.2011
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will receive intra- and extra-ocular surgeries.
Key exclusion criteria Patients having a history of former ocular surgeries.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Tanito
Organization Shimane University Faculty of Medicine
Division name Department of Ophthalmology
Zip code
Address Enya 89-1, Izumo, Shimane, 693-8501
TEL 0853-20-2284
Email tanito0oph@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Tanito
Organization Shimane University Faculty of Medicine
Division name Department of Ophthalmology
Zip code
Address 89-1 Enya, Izumo, 693-8501, Japan
TEL 0853-20-2284
Homepage URL
Email tanito0oph@umin.ac.jp

Sponsor
Institute Departmet of Ophthalmology, Shimane University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 02 Month 24 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000749

Research Plan
Registered date File name
2018/07/30 QOVプロトコールver3.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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