UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study of ocular surface diseases
Title of the study (Brief title)	Retrospective study of ocular surface diseases
Region	Japan

Condition
Condition	ocular surface diseases
Classification by specialty	Ophthalmology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of clinical factors post treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity
Key secondary outcomes	Corneal endothelial density, Central corneal thickness, Severity of conjunctival injection, foveal thickness, cytokine in anterior chamber

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	Post treatment for ocular surface diseases
Key exclusion criteria	Patients who disagree to be involved in the study
Target sample size	2500

Research contact person
Name of lead principal investigator	Koji Kitazawa
Organization	Baptist Eye Institute
Division name	Ophthalmology
Address	12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL	075-721-3800
Email	kkitazaw@koto.kpu-m.ac.jp

Public contact
Name of contact person	Koji Kitazawa
Organization	Baptist Eye Institute
Division name	Ophthalmology
Address	12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL	075-721-3800
Homepage URL
Email	kkitazaw@koto.kpu-m.ac.jp

Sponsor
Institute	Baptist Eye Institute
Institute
Department

Funding Source
Organization	Baptist Eye Institute
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 11 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 05 Month 18 Day
Anticipated trial start date	2012 Year 05 Month 18 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	visual acuity

Management information
Registered date	2016 Year 11 Month 18 Day
Last modified on	2016 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028643