UMIN-CTR Clinical Trial

Basic information
Public title	Long-term prognosis of serous retinal detachment associated with tilted disc syndrome: a retrospective multicenter survey
Acronym	Long-term prognosis of eyes with tilted disc syndrome-associated serous retinal detachment
Scientific Title	Long-term prognosis of serous retinal detachment associated with tilted disc syndrome: a retrospective multicenter survey
Scientific Title:Acronym	Long-term prognosis of eyes with tilted disc syndrome-associated serous retinal detachment
Region	Japan

Condition
Condition	tilted disc syndrome
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate long-term prognosis of eyes with Tilted disc syndrome-associated serous retinal detachment by a multi-center survey.
Basic objectives2	Others
Basic objectives -Others	Observation of long-term prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The best collected visual acuity at baseline and last visit.
Key secondary outcomes	change of serous retinal detachment and central retinal thickness

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosed as TDS-associated serous retinal detachment with follow-up of 12 months or longer
Key exclusion criteria	high myopia
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Yasukawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Ophthalmology and Visual Science
Zip code	467-0001
Address	1 Kawasumi, Mizuho, Nagoya, Japan
TEL	052-853-8251
Email	yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Yasukawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Ophthalmology and Visual Science
Zip code	467-0001
Address	1 Kawasumi, Mizuho, Nagoya, Japan
TEL	052-853-8251
Homepage URL
Email	yasukawa@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
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	clinical research management center
Address	1 Kawasumi, Mizuho, Nagoya, Japan
Tel	052-858-7215
Email	ctmc@med.nagoya-cu.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	2018 Year 11 Month 30 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	48
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	2017 Year 03 Month 30 Day
Date of IRB	2018 Year 04 Month 11 Day
Anticipated trial start date	2018 Year 04 Month 11 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Investigated regarding intervention, histroy of intervention, best collected visual acuity, change of serous retinal detachment and central retinal thickness on optical coherence tomography.

Management information
Registered date	2018 Year 11 Month 29 Day
Last modified on	2020 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039986