UMIN-CTR Clinical Trial

Basic information
Public title	Evaluations of pupil diameter, pupillary unrest and pupillary light reflex by using infrared pupillography in patients with the inner or outer retinal layer diseases
Acronym	Evaluations of pupillary response in the retinal diseases
Scientific Title	Evaluations of pupil diameter, pupillary unrest and pupillary light reflex by using infrared pupillography in patients with the inner or outer retinal layer diseases
Scientific Title:Acronym	Evaluations of pupillary response in the retinal diseases
Region	Japan

Condition
Condition	glaucoma, diabetic retinopathy, age-related macular degeneration, retinitis pigmentosa
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the possibility of inner or outer retinal layer diseases detection by pupillary response and pupillary unrest to different colored light stimulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Latency of pupil constriction Percentage of pupil constriction Percentage of sustained pupil constriction Percentage of pupil recovery Pupillary unrest
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Total 8 interventions
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	30 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	glaucoma, diabetic retinopathy, age-related macular degeneration, retinitis pigmentosa
Key exclusion criteria	multiple eye diseases, postoperation, medication and eyedrops affecting of pupil
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken Asakawa
Organization	Department of Rehabilitation, School of Allied Health Sciences, Kitasato University
Division name	Orthoptics and Visual Science Course
Zip code
Address	1-15-1 Kitasato, Minami-ku, Sagamihara 252-0373, Japan
TEL	042-778-9667
Email	asaken@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Asakawa
Organization	Department of Rehabilitation, School of Allied Health Sciences, Kitasato University
Division name	Orthoptics and Visual Science Course
Zip code
Address	1-15-1 Kitasato, Minami-ku, Sagamihara 252-0373, Japan
TEL	042-778-9667
Homepage URL
Email	asaken@kitasato-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kitasato University Hospital
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 09 Month 25 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 06 Month 23 Day
Date of IRB	2014 Year 06 Month 23 Day
Anticipated trial start date	2014 Year 06 Month 23 Day
Last follow-up date	2019 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2019 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017734