UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of diquafosol sodium ophthalmic solution on visual function in patients following cataract surgery
Title of the study (Brief title)	The effect of diquafosol sodium ophthalmic solutionin 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
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

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

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	90

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

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

Sponsor
Institute	Keio University School 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)

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	2014 Year 11 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 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	2014 Year 11 Month 11 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018206