UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007535 |
|---|---|
| Receipt number | 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 21:54:13 |
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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
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/
takaoh@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university school of medicine
department of ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008902
