UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001646 |
|---|---|
| Receipt number | R000001980 |
| Scientific Title | The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy |
| Date of disclosure of the study information | 2009/01/19 |
| Last modified on | 2009/01/19 16:18:49 |
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Basic information
Public title
The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Acronym
The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Scientific Title
The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Scientific Title:Acronym
The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of NSAID eye drop for cystoid macular edema after panretinal photocoagulation for diabetic retinopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
retina thickness by OCT and cystoid macular edema by FA
Key secondary outcomes
visual acuity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NSAID eye drops
Interventions/Control_2
vitamin eye drops
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HbA1c is under 9%.
Preproliferative or proliferative diabetic retinopathy.
Need panretinal photocoagulation .
Visual acuity is over 20/50.
Retinal thickness is under 400maicro-meter.
Key exclusion criteria
Cannot recieve informed concent.
Treated by NSAID for these 6 months.
Already recieved panretinal photocoagulation.
Treated photocoagulation except pan retinal photocoagulation for these 6 months.
Not suitable for this study.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ibaraki |
Organization
Jichi medical University
Division name
Department of Ophthalmology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-city, Tochigi
TEL
0285-58-7382
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ibaraki |
Organization
Jichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
ibaraki@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Dept. of Ophthalmol., Jichi Medical 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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 01 | 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
Date of protocol fixation
| 2009 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 19 | Day |
Last modified on
| 2009 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001980
