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 |
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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
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
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
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
