UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028453 |
|---|---|
| Receipt number | R000032571 |
| Scientific Title | Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2017/07/31 12:23:50 |
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Basic information
Public title
Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser
Acronym
Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser
Scientific Title
Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser
Scientific Title:Acronym
Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser
Region
| Japan |
Condition
Condition
Severe non-proliferative diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ocular blood flow after panretinal photocoagulation (PRP) in eyes with severe non-proliferative diabetic retinopathy by laser speckle flowgraphy and compare the effect of pattern scan laser and argon laser.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow of retinochoroidal blood vessel
Key secondary outcomes
Choroidal vascular area
Choroidal thickness
Vascular diameter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Argon laser treatment group
The PRP will be delivered through a wide-field contact lens using the argon laser.
The PRP for each eye will be performed in 3 to 5 sessions with an interval of 2 weeks betweeen sessions. For each session, 0.2 m spot sizes with pulse duration of 0.2 seconds. Three hundred to 400 spots will be made for a total to 1200 to 2000 spots for a complete PRP.
Interventions/Control_2
Pattern scan laser treatment group
The PRP will be delivered through a wide-field contact lens using the pattern
scan laser.
The PRP for each eye will be performed in 2 to 3 sessions with an interval of 2 weeks betweeen sessions. For each session, 0.2 m spot sizes with pulse duration of 0.02 seconds. Onethousand to 1500 spots will be made for a total to 4000 to 6000 spots for a complete PRP.
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
Eyes with severe non-proliferative diabetic retinopathy
Key exclusion criteria
Presence of any other eye disease
History of eye disease treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Iwase |
Organization
Nagoya University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
tiwase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Ueno |
Organization
Nagoya University School of Medicine
Division name
Department of Opthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
Homepage URL
ystk.imp@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | 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
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032571
