UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000008903