UMIN-CTR Clinical Trial

Basic information
Public title	longitudinal anatomical and functional changes of optic disc pit maculopathy
Acronym	longitudinal anatomical and functional changes of optic disc pit maculopathy
Scientific Title	longitudinal anatomical and functional changes of optic disc pit maculopathy
Scientific Title:Acronym	longitudinal anatomical and functional changes of optic disc pit maculopathy
Region	Japan

Condition
Condition	optic dis pit maculopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	analysis of longitudinal anatomical and functional changes of optic disc pit maculopathy
Basic objectives2	Others
Basic objectives -Others	observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual field sensitivity and retinal thickness
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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	subject with optic disc pit maculopathy
Key exclusion criteria	subject without cooperation of study
Target sample size	1

Research contact person
Name of lead principal investigator	1st name kei Middle name Last name shinoda
Organization	saitama medical university
Division name	department of ophthalmology
Zip code	3500495
Address	morohogo 38 iruma saitama Japan
TEL	0492761250
Email	shinok@saitama-med.ac.jp

Public contact
Name of contact person	1st name kei Middle name Last name shinoda
Organization	saitama medical university
Division name	department of ophthalmology
Zip code	3500495
Address	morohogo 38 iruma saitama Japan
TEL	0492761250
Homepage URL
Email	shinok@saitama-med.ac.jp

Sponsor
Institute	saitama medical university
Institute
Department

Funding Source
Organization	saitama medical university
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	saitama medical university
Address	morohongo38 iruma saitama japan
Tel	0492762143
Email	rinri@saitama-med.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	2019 Year 09 Month 09 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	Terminated
Date of protocol fixation	2019 Year 09 Month 09 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 09 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	non

Management information
Registered date	2019 Year 09 Month 09 Day
Last modified on	2020 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043282