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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010973
Receipt No. R000012718
Scientific Title The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery exploratory study.
Date of disclosure of the study information 2013/06/17
Last modified on 2017/06/20

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Basic information
Public title The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery exploratory study.
Acronym The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery
Scientific Title The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery exploratory study.
Scientific Title:Acronym The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 To examine whether dry eye symptoms and decrease of visual function in the perioperative period of cataract surgery is improved by treatment with diquafosol sodium ophthalmic solution, and to compare with artificial tears and no treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual function(functional visual acuity, refraction, and so on)
Symptoms (questionnaire, DEQS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diquafosol sodium ophthalmic solution
Interventions/Control_2 Artificial tears
Interventions/Control_3 No treatment
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who are diagnosed as the cataract by the aging of 40 to 85 years old and is going to perform an operation.
2) Patients with preoperative corrected visual acuity more than 0.4.
3) Operation method is trans-conjunctival single-plane incision. 2.4 mm incision fixed.
4) Patients who use the specified intraocular lens.
5) Patients who agree to study entry and can see an ophthalmologist for all observation periods.
Key exclusion criteria 1) Patients who don't meet the above entry criteria.
2) Patients with progressive irregular corneal astigmatism.
3) Cataract by congenital, metabolic, prenatal infection, traumatic, harmful rays, radiation, inflammatory, drug-induced, atopic, systemic disease, a cause other than aging.
4) Patients whom primary doctor judged as inadequacy except for the above.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuno Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinano-machi, Shinnjuku-ku,
TEL 03-5363-3821
Email fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuno Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinano-machi, Shinnjuku-ku,
TEL 03-5363-3821
Homepage URL
Email fwic7788@mb.infoweb.ne.jp

Sponsor
Institute Keio 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)

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 06 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially 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
2012 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 17 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 06 Month 15 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012718

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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