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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000027924 |
Receipt No. | R000031984 |
Scientific Title | A prospective open-label trial; Efficacy of bromfenac sodium ophthalmic solution in preventing cystoid macular oedema after endothelial keratoplasty (DSAEK or DMEK) |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2018/06/03 |
Basic information | ||
Public title | A prospective open-label trial; Efficacy of bromfenac sodium ophthalmic solution in preventing cystoid macular oedema after endothelial keratoplasty (DSAEK or DMEK) | |
Acronym | Prevention of cystoid macla oedema after endothelial keratoplasty using bromfenac | |
Scientific Title | A prospective open-label trial; Efficacy of bromfenac sodium ophthalmic solution in preventing cystoid macular oedema after endothelial keratoplasty (DSAEK or DMEK) | |
Scientific Title:Acronym | Prevention of cystoid macla oedema after endothelial keratoplasty using bromfenac | |
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 | Cystoid macular edema (CME) is a well-described complication of intraocular surgery, particularly after cataract
surgery, and is detected readily by optical coherence tomography (OCT). CME has also been described after various keratoplasty techniques such as penetrating keratoplasty, Descemet stripping automated endothelial keratoplasty, and DMEK. We hypothesise that CME could be controlled by bromfenac sodium ophthalmic solution. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | central foveal thickness preoperatively, and 1, 3, 6, 12 months postoperatively after endothelial keratoplasty |
Key secondary outcomes | the best-corrected visual acuity (BCVA), central corneal thickness(CCT), and corneal endothelial cell density(ECD), preoperatively, and 1, 3, 6, 12 months postoperatively after endothelial keratoplasty |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | EK with topical 0.1% bromfenac sodium
ophthalmic solution |
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Interventions/Control_2 | EK without topical 0.1% bromfenac sodium
ophthalmic solution |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients with bullous keratoplathy, who agree with this study | |||
Key exclusion criteria | patients without bullous keratoplathy, who agree with this study | |||
Target sample size | 40 |
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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 | 0457822101 | ||||||
takamed@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | 0457822101 | ||||||
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 |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Terminated | ||||||
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Other | |
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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=R000031984 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |