UMIN-CTR Clinical Trial

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
Email	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
Email	takamed@gmail.com

Sponsor
Institute	Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department

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
Email

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
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

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