UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007536 |
|---|---|
| Receipt number | R000008903 |
| Scientific Title | Use of nonmydriatic spectral-domain optical coherence tomography for diagnosing and treating diabetic macular edema |
| Date of disclosure of the study information | 2012/03/20 |
| Last modified on | 2019/03/26 12:10:52 |
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Basic information
Public title
Use of nonmydriatic spectral-domain optical coherence tomography for diagnosing and treating diabetic macular edema
Acronym
Use of nonmydriatic OCT for diagnosing and treating diabetic macular edema
Scientific Title
Use of nonmydriatic spectral-domain optical coherence tomography for diagnosing and treating diabetic macular edema
Scientific Title:Acronym
Use of nonmydriatic OCT for diagnosing and treating diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the accuracy of spectral-domain optical coherence tomography (OCT)devices before and after mydriasis for the diagnosis and treatment of diabetic retinopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity,intraocular pressure,macular thickness and retinal nerve fiber thickness
(before and after mydriasis)
Key secondary outcomes
subjective symptom
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
mensuration of central retinal thickness and reinal nerve fiber thickness by SD OCT instruments before and after pupil dilation
Interventions/Control_2
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
| 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 creteria for diabetes
Without medical examination within 1 year
Adequate pupil dilatation and clear media to perform digital photography and OCT scans
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)
Any previous surgical or laser treatment to the study eye
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Hirano |
Organization
Shinshu university school of midecine
Division name
department of ophthalmology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japanagano
TEL
+81-263-37-2664
takaoh@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Hirano |
Organization
Shinshu university school of medicine
Division name
department of ophthalmology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japanagano
TEL
+81-263-37-2664
Homepage URL
takaoh@shinshu-u.ac.jp
Sponsor or person
Institute
Takao Hirano
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
Shinshu University Review Board of Clinical Research
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Japan
Tel
0263-37-2576ext.5153
ieganka@shinshu-u.ac.jp
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）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 20 | 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 | 20 | 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 | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
