UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013474 |
|---|---|
| Receipt number | 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 17:20:04 |
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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
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
akikato@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science.
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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