UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impacts of indocyanine green angiography-guided laser photocoagulation on diabetic macular edema
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tsutomu Yasukawa
Organization	Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name	Department of Ophthalmology and Visual Science
Address	1 Kawasumi, Mizuho, Nagoya
TEL	052-853-8251
Email	yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Aki Kato
Organization	Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name	Department of Ophthalmology and Visual Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015694