UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027923 |
|---|---|
| Receipt number | R000031981 |
| Scientific Title | A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/06/03 12:01:18 |
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Basic information
Public title
A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Acronym
Change of NEI VFQ-25 subscale score after Endothelial Keratoplasty
Scientific Title
A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Scientific Title:Acronym
Change of NEI VFQ-25 subscale score after Endothelial Keratoplasty
Region
| Japan |
Condition
Condition
bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endothelial keratoplasty, such as Descemet stripping automated endothelial keratoplasty (DSAEK), or Descemet membrane endothelial keratoplasty (DMEK), is expected to provide better visual function. However, the correlation between visual acuity and the quality of vision has not been well understood until now. We have to analyze the quality of life after endothelial keratoplasty using the NEI VFQ-25 subscale score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
best-corrected visual acuity, corneal endothelial cell density, and central corneal thickness preoperatively and 6 months postoperatively vfq25 High-order aberrations
Key secondary outcomes
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 with bullous keratopathy, who are treated with DSAEK or DMEK under agreement with this study
Key exclusion criteria
patients who disagree with this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiko Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Ophthalmology
Zip code
Address
1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-782-2101
takamed@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Opthalmology
Zip code
Address
1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872101
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
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 | 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
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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031981
