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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013474
Receipt No. R000015694
Scientific Title Impacts of indocyanine green angiography-guided laser photocoagulation on diabetic macular edema
Date of disclosure of the study information 2014/03/20
Last modified on 2016/06/02

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Basic information
Public title Impacts of indocyanine green angiography-guided laser photocoagulation on diabetic macular edema
Acronym ICGA-guided laser photocoagulation for diabetic macular edema
Scientific Title Impacts of indocyanine green angiography-guided laser photocoagulation on diabetic macular edema
Scientific Title:Acronym ICGA-guided laser photocoagulation for diabetic macular edema
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the usefulness of indocyanine green angiography-guided assessment and laser photocoagulation for diabeic macular edema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes best-corrected visual acuities
Key secondary outcomes fluorescein-indocyanine green angiography
central macular thickness
macular volume

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Fluorescein angiography/indocyanine green angiography (FA/IA) was performed with the patients who was diagnosed diffuse diabetic macular edema by FA and IA-guided PHC was performed on the basis of middle or late phase IA.
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who met all criteria as below:
1)The patients who were diagnosed as diabetic macular edema.
2)The patients whose baseline logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) were within of 0.15 to 1.30, CRT and MV , 200 to 700 micro meter, 10.0-15.0mm3 , respectively
Key exclusion criteria The patients who met one of the items as below:
1)The patients who had undergone scattered (panretinal) photocoagulation within six months, treated previously with triamcinolone within 12 weeks,
2)The patients who had allergy to FA or ICGA.
3)The patients who has dense vitreous hemorrhage or opacity in the media such as remarkable cataract which disturbs photocoagulation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Yasukawa
Organization Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho, Nagoya
TEL 052-853-8251
Email yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aki Kato
Organization Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho, Nagoya
TEL 052-853-8251
Homepage URL
Email akikato@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual Science.
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department

Funding Source
Organization Department of Ophthalmology and Visual Science.
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
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
2014 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 20 Day
Last modified on
2016 Year 06 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015694

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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