UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030971
Receipt number R000035361
Scientific Title Rapid diagnosis of intraocular diseases using intraocular fluids/specimens.
Date of disclosure of the study information 2018/02/01
Last modified on 2018/01/24 12:42:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Rapid diagnosis of intraocular diseases using intraocular fluids/specimens.

Acronym

Rapid diagnosis of intraocular diseases.

Scientific Title

Rapid diagnosis of intraocular diseases using intraocular fluids/specimens.

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroshi Takase

Organization

Tokyo Medical and Dental University

Division name

Ophthalmology

Zip code


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

1st name
Middle name
Last name Hiroshi Takase

Organization

Tokyo Medical and Dental University

Division name

Ophthalmology

Zip code


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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Open public recruiting

Date of protocol fixation

2000 Year 01 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name