UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in retinal microcirculation after panretinal photocoagulation in eyes with severe non-proliferative diabetic retinopathy : pattern scan laser versus argon laser
Title of the study (Brief title)	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	Takeshi Iwase
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
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	Yoshitaka Ueno
Organization	Nagoya University School of Medicine
Division name	Department of Opthalmology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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