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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007535
Receipt No. R000008902
Scientific Title To investigate the effects of panretinal photocoagulation by a multicolor laser photocoagulator with a scan delivery system in eyes with proliferative daibetic retinopathy
Date of disclosure of the study information 2012/03/19
Last modified on 2012/03/19

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Basic information
Public title To investigate the effects of panretinal photocoagulation by a multicolor laser photocoagulator with a scan delivery system in eyes with proliferative daibetic retinopathy
Acronym To investigate the effects of panretinal photocoagulation by the MC-500 Vixi
Scientific Title To investigate the effects of panretinal photocoagulation by a multicolor laser photocoagulator with a scan delivery system in eyes with proliferative daibetic retinopathy
Scientific Title:Acronym To investigate the effects of panretinal photocoagulation by the MC-500 Vixi
Region
Japan

Condition
Condition diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of panretinal photocoagulation by a multicolor laser photocoagulator with a scan deliverysystem on pain score, operation time, visual acuity, visual field, macular thickness and nerve fiber thickness in eyes with diabetic retinopathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes pain score, operation time, visual acuity, visual field, macular thickness and nerve fiber thickness
(at baseline, 3 months, 6 months, one year)
Key secondary outcomes subjective symptom

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 no treatment
Interventions/Control_2 photocoagulation with a multicolor laser photocoagulator with a scan delivery system
Interventions/Control_3 photocoagulation with a conventional photocoagulator
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Male or female patients with diabetis mellitus type 1 or 2 who meet the WHO or ADA criteria for diabetes
Snellen equvalent of 6/60 or better
Newly diagnosed PDR
Adequate pupil dilatation and clear media to perform laser photocoagulation, digital photography and OCT scans
Ability to perform accurate Humphrey visual field test
Key exclusion criteria Recent (last 6 months) or ongoing poor glycaemic control(HbA1c greater than 10.0mg/dl)
Uncontrolled hypertension (BP greater than 180/110mmHg)
History of chronic renal failure or renal transplant for diabetic nephropathy
Any previous surgical or laser treatment to the study eye
Planned intra-ocular surgery within 1 year
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Hirano
Organization Shinshu university school of medicine
Division name department of ophthalmology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81-263-37-2664
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takaoh Hirano
Organization Shinshu university school of medicine
Division name department of ophthalmology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81-263-37-2664
Homepage URL http://www.shinshu-u.ac.jp/faculty/medicine/chair/i-ganka/
Email takaoh@shinshu-u.ac.jp

Sponsor
Institute Shinshu university school of medicine
department of ophthalmology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 信州大学附属病院(長野県)、長野赤十字病院(長野県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 19 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 Enrolling by invitation
Date of protocol fixation
2012 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 19 Day
Last modified on
2012 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008902

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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