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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030390
Receipt No. R000034693
Scientific Title Direct photocoagulation guided by merged retinal images for the treatment of focal diabetic macular edema
Date of disclosure of the study information 2017/12/13
Last modified on 2017/12/13

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Basic information
Public title Direct photocoagulation guided by merged retinal images for the treatment of focal
diabetic macular edema
Acronym Direct photocoagulation guided by merged retinal images
Scientific Title Direct photocoagulation guided by merged retinal images for the treatment of focal
diabetic macular edema
Scientific Title:Acronym Direct photocoagulation guided by merged retinal images
Region
Japan

Condition
Condition diabetic macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To introduce a novel laser photocoagulation (PC) protocol named merged image-guided PC (MIG-PC), which included merging the images of the fundus, optical coherence tomography (OCT) map, and fluorescein angiography (FA). We compared the anatomical and functional results between MIG-PC and FA-guided PC (FG-PC) for the treatment of focal diabetic macular edema (DME).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, retinal thickness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Merged images guided photocoagulation
Interventions/Control_2 fluorescein angiography guided photocoagulation
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
90 years-old >=
Gender Male and Female
Key inclusion criteria focal diabetic macular edema
Key exclusion criteria a history of prior vitrectomy in the study eye; history of anti-VEGF injections received within 3 months; history of PRP within 6 months; and presence of medial opacity, such as severe cataract, corneal opacity, or vitreous hemorrhage.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL +81-776-61-8403
Email ytakamura@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Shimoaiduki Matsuoka Eiheiji Yoshida Fukui
TEL +81-776-61-8403
Homepage URL
Email ytakamura@hotmail.com

Sponsor
Institute others
Institute
Department

Funding Source
Organization Faculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization Self funding
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 12 Month 13 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 13 Day
Last modified on
2017 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034693

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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