UMIN-CTR Clinical Trial

Basic information
Public title	Micro changes of ophthalmic video using motion and color magnification
Acronym	Micro changes of ophthalmic video
Scientific Title	Micro changes of ophthalmic video using motion and color magnification
Scientific Title:Acronym	Micro changes of ophthalmic video
Region	Japan

Condition
Condition	Cataract, glaucoma, chorioretinal deseases, ischemic ophthalmic diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Micro motion or color changes of ocular structures are assessed using motion or color magnification methods in ocular diseases.
Basic objectives2	Others
Basic objectives -Others	Relationship between micro changes of ocular structures and patients' background are investigated.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Micro changes of ocular structure
Key secondary outcomes	Patients' background in usual care

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Cataract, glaucoma, chorioretinal diseases or ischemic ophthalmic diseases eyes that are recorded by ophthalmic video.
Key exclusion criteria	Disagreement of patients
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Taiji Middle name Last name Sakamoto
Organization	Kagoshima university medical and dental hospital
Division name	Ophthalmology
Zip code	890-8544
Address	8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL	099-275-5402
Email	tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Takehiro Middle name Last name Yamashita
Organization	Kagoshima university medical and dental hospital
Division name	Ophthalmology
Zip code	890-8544
Address	8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL	099-275-5402
Homepage URL
Email	take1@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima university
Institute
Department

Funding Source
Organization	Self funding
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	Kagoshima University Hospital
Address	8-35-1 Sakuragaoka Kagoshima Japan
Tel	099-275-6692
Email	kufsyomu@kuas.kagoshima-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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 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	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 20 Day
Date of IRB	2016 Year 07 Month 30 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2028 Year 03 Month 31 Day

Other
Other related information	Observational period: 15 years from 31/03/2026 Methods: Ophthalmic videos and patients' background in usual care

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026883