UMIN-CTR Clinical Trial

Basic information
Public title	Examination of eye diseases with adaptive optics scanning laser ophthalmoscopy
Acronym	AO-SLO for eye diseases
Scientific Title	Examination of eye diseases with adaptive optics scanning laser ophthalmoscopy
Scientific Title:Acronym	AO-SLO for eye diseases
Region	Japan

Condition
Condition	Diabetic retinopathy, age-related macular degeneration, retinitis pigmentosa, the other retinal diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine photoreceptor and retinal blood vessels in retinal diseases with AO-SLO
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between cone mosaic, dynamic state of blood flow and visual function in retinal dieases
Key secondary outcomes

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	Adaptive Optics Scanning Laser Ophthalmoscopy
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patient group: Patients with diabetes retinopathy, age related macular degeneration, retina pigment denaturation, other retina diseases in Kyushu University Hospital ophthalmology. Control group: Person who do not have any retinal disease in Kyushu University Hospital ophthalmology, and there is not the systemic disease including diabetes and hypertension. (2) Person who can understand this study plan enough, and the agreement by the person is possible. (3) Age at the time of the agreement acquisition; one 20 years or older.
Key exclusion criteria	(1) Person with the past which is a side effect (hyperesthesia and the eyes pressure rise) to mydriasis eye drop. (2) Person with shallow anterior chamber (3) Person who id judged that he is not suitable as a subject by a researcher.
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shintaro Nakao
Organization	Kyushu University
Division name	Ophthalmology
Zip code
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	81-92-642-5648
Email	snakao@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shintaro Nakao
Organization	Kyushu University
Division name	Department of Ophthalmology
Zip code
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	81-92-642-5648
Homepage URL
Email	snakao@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	JSPS KAKENHI, Grant-in-Aid for Young Scientists (A) No. 25713057
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Canon Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 03 Month 24 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	2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date	2013 Year 04 Month 12 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded	2016 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2015 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017495

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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