UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rapid diagnosis of intraocular diseases using intraocular fluids/specimens.
Title of the study (Brief title)	Rapid diagnosis of intraocular diseases.
Region	Japan

Condition
Condition	Uveitis Intraocular lymphoma
Classification by specialty	Ophthalmology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish accurate and rapid methods to diagnose infectious intraocular inflammatory diseases or intraocular lymphoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of genomes or proteins specific for pathogenic microbes or lymphoma using polymerase chain reaction, antibody measurement, or cytokine analysis.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Sampling of tear fluid: wash the ocular surface of the patient with supine position using saline, and collect 20 ul of diluted tear fluid. Sampling of conjunctiva: wash the ocular surface using iodine solution, open the eyelid using lid retractor, and excise 1mm x 3mm of the conjunctiva fornicis using micro scissors. To prevent the infection, use eye drop and ophthalmic ointment of antibiotics. Sampling of corneal tissues: Under surgical microscope, collect the corneal epithelial cells by pressing a 2mm square of paper filter to the corneal surface, or collect the corneal epithelial and parenchymal cells directly by scraping the focus in the cornea using sharp needle. Sampling of aqueous humor: wash the ocular surface using iodine solution in the treatment room of the outpatient, and collect about 0.1ml of aqueous humor via corneal limbus using 30-guage needle under surgical microscope. To prevent the infection, use eye drop and ophthalmic ointment of antibiotics. Sampling of iris, trabecular meshwork, or vitreous fluid: collect iris, trabecular meshwork, or vitreous fluid when they are excised and discarded during surgery for the treatment purpose in the operation room.
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 with intraocular inflammation who are suspected to be suffering from infectious diseases or intraocular lymphoma.
Key exclusion criteria	Those who do not agree with this study.
Target sample size	1000

Research contact person
Name of lead principal investigator	Hiroshi Takase
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL	03-3813-6111
Email	h.takase.oph@tmd.ac.jp

Public contact
Name of contact person	Hiroshi Takase
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL	03-3813-6111
Homepage URL
Email	h.takase.oph@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2000 Year 01 Month 01 Day
Anticipated trial start date	2000 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035361