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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007536
Receipt No. 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

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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
Email 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
Email takaoh@shinshu-u.ac.jp

Sponsor
Institute Takao Hirano
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 Shinshu University Review Board of Clinical Research
Address 3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Japan
Tel 0263-37-2576ext.5153
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008903

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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