UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034865
Receipt number R000039752
Scientific Title 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 2019/05/14 09:43:32

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Basic information

Public title

Survey on improvement of quality of life after cataract surgery in elderly patients

Acronym

cataract surgery and quality of life

Scientific Title

Survey on improvement of quality of life after cataract surgery in elderly patients

Scientific Title:Acronym

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

1st name Tomoaki
Middle name
Last name Shiba

Organization

Toho University Omori Medical Center

Division name

Ophthalmology

Zip code

143-8541

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

1st name Tomoaki
Middle name
Last name Shiba

Organization

Toho University Omori Medical Center

Division name

Ophthalmology

Zip code

143-8541

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Homepage URL


Email

tomoaki-s@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University

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

Inrtitutional Review Board, Toho University Omori Medical Center

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo

Tel

03-3762-4151

Email

omori.rinri@ext.toho-u.ac.jp


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


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

Preinitiation

Date of protocol fixation

2018 Year 10 Month 11 Day

Date of IRB

2018 Year 10 Month 11 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 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

2018 Year 11 Month 12 Day

Last modified on

2019 Year 05 Month 14 Day



Link to view the page

Value
https://center6.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