UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015250 |
|---|---|
| Receipt number | R000017734 |
| 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 |
| Date of disclosure of the study information | 2014/09/25 |
| Last modified on | 2019/07/18 11:40:19 |
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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
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
asaken@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology,
Kitasato University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017734
