UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028453
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ystk.imp@gmail.com

Sponsor
Institute Nagoya University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.