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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034865
Receipt No. R000039752
Official scientific title of the study Survey on improvement of quality of life after cataract surgery in elderly patients
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/12

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Basic information
Official scientific title of the study Survey on improvement of quality of life after cataract surgery in elderly patients
Title of the study (Brief title) cataract surgery and quality of life
Region
Japan

Condition
Condition cataract in elder patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate improvement of quality of visual function, cognitive function, health, sleep and carer after bilateral cataract surgeries in patients with over 75 years by interview.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of vision:visual functioning questionnaire-11:VFQ-11, mini-mental state examination: MMSE, quality of life: MOS 36-Item Short-Form Health Survey: SF36,Epworth Sleepness Scale: ESS,Burden index of Caregiver: BIC11
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 interview
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
75 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria Bilateral cataract surgeries
Key exclusion criteria Patients who can not interview
Target sample size 100

Research contact person
Name of lead principal investigator Tomoaki Shiba
Organization Toho University Omori Medical Center
Division name Ophthalmology
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email tomoaki-s@med.toho-u.ac.jp

Public contact
Name of contact person Tomoaki Shiba
Organization Toho University Omori Medical Center
Division name Ophthalmology
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Homepage URL
Email tomoaki-s@med.toho-u.ac.jp

Sponsor
Institute Toho University
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)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 11 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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=R000039752

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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