UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010973 |
|---|---|
| Receipt number | 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 18:06:16 |
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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
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
fwic7788@mb.infoweb.ne.jp
Sponsor or person
Institute
Keio 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012718
