UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030390 |
|---|---|
| Receipt number | 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 | 2023/06/19 16:32:52 |
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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 | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
910-1193
Address
23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL
+81-776-61-8403
ytakamura@hotmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaiduki Matsuoka Eiheiji Yoshida Fukui
TEL
+81-776-61-8403
Homepage URL
ytakamura@hotmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
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
Committee of University of Fukui
Address
23-3 Shimoaiduki Matsuoka Eiheiji Yoshida Fukui
Tel
0776-61-8403
ytakamura@hotmail.com
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 18 | Day |
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
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034693
| 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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| Registered date | File name |
