UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the Etiology of Eye Diseases
Acronym	Investigation of the Eye Diseases
Scientific Title	Investigation of the Etiology in Retinal Pigment Epithelium of Macular Diseases
Scientific Title:Acronym	Investigation of the Macular Diseases
Region	Japan

Condition
Condition	Macular diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we clarify that the retinal pigment epithelium disorder of macular area using short- and long-wavelength autofluorescence, and optical coherence tomography.
Basic objectives2	Others
Basic objectives -Others	Serous retinal detachment, bleeding, Bruch's membrane deposit
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of abnormality of retinal pigment epithelium
Key secondary outcomes

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	25 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients who visited the university facility for examination for macular disease during the period were eligible for this study.If patient consent is obtained, they will be enrolled in this study.
Key exclusion criteria	Patients with iodine allergy or fluorescein allergy. Patients who have not obtained consent for this study.
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Ari Middle name Last name Shinojima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	+81-3-5363-3204
Email	ari.shinojima@keio.jp

Public contact
Name of contact person	1st name Ari Middle name Last name Shinojima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	+81-3-5363-3204
Homepage URL
Email	ari.shinojima@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	JSPS
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	Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku
Tel	+81-3-5363-3204
Email	ari.shinojima@keio.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	2020 Year 07 Month 10 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	22
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	2019 Year 09 Month 30 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2021 Year 02 Month 11 Day
Date of closure to data entry	2021 Year 02 Month 11 Day
Date trial data considered complete	2021 Year 02 Month 11 Day
Date analysis concluded	2021 Year 02 Month 11 Day

Other
Other related information	Observational Study

Management information
Registered date	2019 Year 09 Month 20 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043388