UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009772 |
|---|---|
| Receipt number | R000011431 |
| Scientific Title | evaluation of new visual acuity test using psychometric function curve in cataract patients |
| Date of disclosure of the study information | 2013/01/13 |
| Last modified on | 2014/06/05 21:13:49 |
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Basic information
Public title
evaluation of new visual acuity test using psychometric function curve in cataract patients
Acronym
visual acuity test using psychometric function curve
Scientific Title
evaluation of new visual acuity test using psychometric function curve in cataract patients
Scientific Title:Acronym
visual acuity test using psychometric function curve
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the results of new visual acuity test using psychometric function curve with the results of other visual function test in cataract patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity value
Key secondary outcomes
The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25), contrast sensitivity, optical properties of the eye
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cataract surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who have cataract surgery
Key exclusion criteria
patients who have ocular diseases other than cataract, patients whose preoperative corrected visual acuity is less than 0.3
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomofusa Yamauchi |
Organization
San-eikai Tsukazaki Hospital
Division name
Department of ophthalmology
Zip code
Address
68-1 Waku Aboshi-ku Himeji Hyogo Japan
TEL
0792728555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomofusa Yamauchi |
Organization
San-eikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
Address
68-1 Waku Aboshi-ku Himeji Hyogo Japan
TEL
0792728555
Homepage URL
t.yamauchi@tsukazaki-eye.net
Sponsor or person
Institute
San-eikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
San-eikai Tsukazaki Hospital
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 | 01 | Month | 13 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 13 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2014 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011431
