UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective multi-center case series study for posterior segment disease.
Title of the study (Brief title)	Multi-center case series study for posterior segment disease.
Region	Japan

Condition
Condition	Posterior segment disease.
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There are limited surgical cases only at own facility, but to secure sufficient sample size by multi-center
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity intraocular pressure intraoperative complication postoperative complication
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who need surgical treatment for posterior segment disease.
Key exclusion criteria	Patients who are not undergoing surgery treatment
Target sample size	500

Research contact person
Name of lead principal investigator	Chie Sotozono
Organization	Kyoto Prefectual Univercity of Medicine
Division name	Department of Ophthalmology
Address	465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL	075-251-5578
Email	csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yoichiro Shinkai
Organization	Kyoto Prefectual Univercity of Medicine
Division name	Department of Ophthalmology
Address	465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL	075-251-5578
Homepage URL
Email	yshinkai@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology
Institute
Department

Funding Source
Organization	Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Ophthalmology, Oshima Eye Clinic, Takatsuki, Japan. Department of Ophthalmology, Osaka city University Graduate School of Medicine, Osaka, Japan. Department of Ophthalmology, Kobe University Graduate School of Medicine, Kobe, Japan. Department of Ophthalmology, Jikei University School of Medicine, Tokyo, Japan. Department of Ophthalmology, Marianna University School of Medicine, Kanagawa, Japan. Department of Ophthalmology, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan. Department of Ophthalmology, the Keiyu Hospital, Kanagawa, Japan. Department of Ophthalmology, Fukui Red Cross Hospital, Fukui, Japan. Department of Ophthalmology, the MIE Ganka, Yotsukaichi, Japan. Department of Ophthalmology, Okanami General Hospital, Iga, Japan. Department of Ophthalmology, the Mikawa Eye Clinic, Saga, Japan. Department of Ophthalmology, Kozawa Eye Hospital and Diabetes Center, Mito Japan.
Name of secondary funｄer(s)

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 02 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Presented in part at: the American Academy of Ophthalmology Annual Meeting, November 11-14, 2017, New Orleans, America.

Management information
Registered date	2018 Year 02 Month 01 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035519