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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004256
Receipt No. R000004990
Scientific Title Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Date of disclosure of the study information 2010/09/23
Last modified on 2015/03/24

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Basic information
Public title Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Acronym Utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Scientific Title Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Scientific Title:Acronym Utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Region
Japan

Condition
Condition Ocular diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To use measurements of ocular surface temperature obtained by Ocular Surface Thermography in order to diagnose, treat, and elucidate the mechanisms of pathological conditions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Collection of data from normal subjects
2. Temperature changes due to dry eye
3. Changes in the surface temperature of filtering blebs after surgical treatment for glaucoma (trabeculectomy)
4. Temperature changes influenced by insertion, removal or changes in contact lenses
5. Temperature changes in degenerative disorders of the cornea or conjunctiva
6. Temperature changes in infectious or inflammatory ocular diseases
7. Temperature changes after laser treatments (especially iridotomy)
8. Temperature changes after invasive surgery (cataract, vitreous body, cornea, conjunctiva, glaucoma)
9. Temperature changes in chronic glaucoma
Ocular surface temperature will be measured and recorded, and values will be calculated for various regions of the cornea and conjunctiva (temporal, nasal, superior, inferior) and ocular lesions. Values for outcomes 1-9 will be analyzed to determine whether they can be used for diagnosis of ocular diseases, and whether they reflect the severity of pathology or degree of recovery.
Key secondary outcomes Verify device safety

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Normal subjects
2. Dry eye
3. Post-glaucoma surgery
4. Contact lens users
5. Degenerative diseases of the cornea or conjunctiva
6. Infectious or inflammatory ocular diseases
7. Post-laser treatment (especially iridotomy)
8. Post-invasive surgery (cataract, vitreous body, cornea, conjunctiva, glaucoma)
9. Chronic glaucoma
Key exclusion criteria This thermography device is non-invasive, but subjects who feel stress as a result of the Ocular Surface Thermography examination, or those who experience an allergic reaction or foreign body sensation during eye drop instillation will be excluded from the study.
Target sample size 550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Kawasaki
Organization Ehime University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL 089-960-5361
Email kawasaki.eye.clinic@ray.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Shiraishi
Organization Ehime University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL 089-960-5361
Homepage URL
Email shiraia@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Ehime 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 愛媛大学医学部付属病院(愛媛県) Ehime University Hospital (Ehime Prefecture)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The decrease in the ocular surface
temperature in dry eyes was significantly greater than that in normal eyes (P < .001) at 10 seconds after eye opening.
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 Main results already published
Date of protocol fixation
2007 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information We found that Ocular Surface Thermography is useful for diagnosis of dry eye, and are in the process of submitting a journal article regarding our results.

Management information
Registered date
2010 Year 09 Month 22 Day
Last modified on
2015 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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