UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026970 |
|---|---|
| Receipt number | R000030929 |
| Scientific Title | On the relation between the tear layer and the quality of visual acuity after cataract surgery |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2017/04/12 20:09:24 |
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Basic information
Public title
On the relation between the tear layer and the quality of visual acuity after cataract surgery
Acronym
tear layer and the quality of visual acuity after cataract surgery
Scientific Title
On the relation between the tear layer and the quality of visual acuity after cataract surgery
Scientific Title:Acronym
tear layer and the quality of visual acuity after cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We believe that as a cause of this cataract postoperative intolerance, declining tear fluid quality affects the eye optics. The purpose of this study is to elucidate the relationship between tear fluid and quality of visual acuity in patients after cataract surgery
Basic objectives2
Others
Basic objectives -Others
We believe that as a cause of this cataract postoperative intolerance, declining tear fluid quality affects the eye optics. The purpose of this study is to elucidate the relationship between tear fluid and quality of visual acuity in patients after cataract surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tear Meniscus Volume Using the DR-1 Tear Specular Scope
Key secondary outcomes
Contrast sensitivity measurement
Practical vision measurement
Wave front analyzer
Thermometer
Schirmer test paper
Tropicamide/phenylephrine
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
| Device,equipment |
Interventions/Control_1
1 month after cataract operation
Contrast sensitivity measurement
Practical vision measurement
Wave Front Analyzer
Tear film layer imaging device
Thermometer
Schirmer test paper
Tropicamide/phenylephrine
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Toho University Medical Center Omori Hospital Ophthalmic Department of Ophthalmology,cataract surgery, understand the purpose of this research in patients whose corrected visual acuity is (0.8) or more at the consultation for 1 month after surgery Patient agreed with informed consent
Key exclusion criteria
Postoperative of juvenile cataract (less than 40 years old)
Patients with a history of ophthalmic surgery other than cataract surgery
Patients with ocular diseases other than cataract (diabetic retinopathy, retinal vein occlusion, retinal frontal membrane, glaucoma, uveitis, corneal opacity, corneal corruption astigmatism)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUICHI HORI |
Organization
Toho unversity omori hospital
Division name
Ophthalmology
Zip code
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
yhori@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUKINOBU OKAJIMA |
Organization
Toho unversity omori hospital
Division name
Ophthalmology
Zip code
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
Homepage URL
yukinobu.okajima@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
Other
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
| 2017 | Year | 04 | Month | 12 | 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
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2017 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030929
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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