UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027924 |
|---|---|
| Receipt number | 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 12:01:53 |
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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
| Japan |
Condition
Condition
Bullous keratopathy
Classification by specialty
| Ophthalmology |
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
| Medicine |
Interventions/Control_1
EK with topical 0.1% bromfenac sodium
ophthalmic solution
Interventions/Control_2
EK without topical 0.1% bromfenac sodium
ophthalmic solution
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
| 120 | years-old | > |
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
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
0457822101
takamed@gmail.com
Public contact
Name of contact person
| 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
0457822101
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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
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=R000031984
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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