UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027626 |
|---|---|
| Receipt number | R000031653 |
| Scientific Title | A prospective study in the visual quality of pterygium surgery |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/06/04 23:06:51 |
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Basic information
Public title
A prospective study in the visual quality of pterygium surgery
Acronym
The effect on the the visual quality of the pterygium surgery
Scientific Title
A prospective study in the visual quality of pterygium surgery
Scientific Title:Acronym
The effect on the the visual quality of the pterygium surgery
Region
| Japan |
Condition
Condition
Pterygium
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the analyzing the high order aberrations (HOAs), spherical aberrations, and Coma abberations of anterior, posterior, and total cornea before and after pterigium surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
logMAR,astigmatism, high-order aberrations(HOAs), spherical aberrations, coma aberrations, VFQ-25
Key secondary outcomes
VAS score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients of pterygium, who agree with this study
Key exclusion criteria
patients who dont agree with this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIKO |
| Middle name | |
| Last name | HAYASHI |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
2360037
Address
1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Japan
TEL
81457872101
htakahiko-aikou@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
2360037
Address
Kanazawa-ku
TEL
+817038502167
Homepage URL
takamed@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Yokohama Minami Kyosai Hospital
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
Yokohama Minami Kyosai Hospital
Address
1-21-1, Mutsuura-Higashi
Tel
+81457872101
htakahiko-aikou@umin.ac.jp
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 | 07 | Month | 01 | 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
50
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
the lack of statistic method
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
a prospective observational study
Management information
Registered date
| 2017 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031653
