UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012470 |
|---|---|
| Receipt number | R000014599 |
| Scientific Title | Assessment of efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema |
| Date of disclosure of the study information | 2013/12/03 |
| Last modified on | 2015/01/09 15:13:34 |
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Basic information
Public title
Assessment of efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Acronym
Efficacy of NAVILAS laser with IA guided for diffuse macular edema
Scientific Title
Assessment of efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Scientific Title:Acronym
Efficacy of NAVILAS laser with IA guided for diffuse macular edema
Region
| Japan |
Condition
Condition
Diffuse macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of Navigated Retina Laser Therapy (NAVILAS) with Indocyanine Green Angiography-guided for diffuse macular edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
best corrected visual acuity (BCVA)
Central retinal thickness measured by Cirrus OCT
Key secondary outcomes
macular volume measured by Cirrus OCT
Intraocular pressure
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
| Device,equipment |
Interventions/Control_1
Navigated Retina Laser Therapy (NAVILAS)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient must have diffuse macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
Key exclusion criteria
any intraocular sugary or sub-Tenon's capsule Steroid injection within 3 months prior to study entry.
any laser photocoagulation within 6 months prior to study entry.
any case who can not detect macular detail by OCT due to cataract
can not do fluorescein angiography due to renal dysfunction
patients who are currently taking systemic steroid
patients who are pregnant, or have possibility of pregnant
eyes with membrane traction by OCT
the patients whose doctor admit not ideal to entry to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ogura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya JAPAN
TEL
052-853-8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Nozaki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya JAPAN
TEL
052-853-8251
Homepage URL
nozakim@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ellex
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 05 | 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
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014599
