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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000027923 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | bullous keratopathy | |
Classification by specialty |
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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 |
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Base | |
Study type | Observational |
Study design | |
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Randomization | |
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Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Ophthalmology, Yokohama Minami Kyosai Hospital |
Institute | |
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Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | None |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031981 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |