UMIN-CTR Clinical Trial

Basic information
Public title	Functional evaluation of the retinal photoreceptor
Acronym	Functional evaluation of the retinal photoreceptor
Scientific Title	Functional evaluation of the retinal photoreceptor
Scientific Title:Acronym	Functional evaluation of the retinal photoreceptor
Region	Japan

Condition
Condition	Retinal degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The retinal degenerations reduce visual acuity because visual acuity has consisted on the high cone density at the fovea. According to World Health Organization, the blindness and low vision ratio in Japan are 0.14% and 0.39% respectively. The prognosis of retinal degenerations depends on the stage. Therefore, establishing a test method, which detect the retinal degeneration in early stage, expect to reduce the blindness and low vision ratio. Also, that leads to increasing the quality of life in patients with retinal degeneration. The goal of our study is to establish the new detecting test with the retinal degenerations, which has high detection capability compared with the conventional method, by combining the photobleaching and the adaptive optics scanning laser ophthalmoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	photoreceptor reflectance changes
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	Prevention
Type of intervention	Other
Interventions/Control_1	light stimulation of up to 5 minutes
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	No eye disease without refractive error Volunteers who were informed of this study and consented to participate
Key exclusion criteria	Volunteers who have eye disease without refractive error
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takashi Fujikado
Organization	Osaka university graduate school of medicine
Division name	Department of applied visual science
Zip code
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3941
Email	fujikado@ophthal.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroyuki Kanda
Organization	Osaka university graduate school of medicine
Division name	Department of applied visual science
Zip code
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3943
Homepage URL
Email	kanda@sensory.med.osaka-u.ac.jp

Sponsor
Institute	Department of applied visual science, Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization	Department of applied visual science, Osaka university graduate school of medicine
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
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 10 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Date of IRB	2014 Year 09 Month 04 Day
Anticipated trial start date	2014 Year 09 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 13 Day
Last modified on	2019 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022343